JOIN OUR TEAM
BioGX is a growing company. We are always on the lookout for talented scientists and technicians with an entrepreneurial spirit, a dedication to excellence, and experience with molecular detection methods and general molecular biology. We offer a competitive salary and benefits package. Please check our currently available positions below.
Clinical Affairs Manager
BioGX – Birmingham, AL
***Please include a cover letter explaining why you are the best candidate for this position.***
Purpose of the Position:
Provides leadership, direction and support for the implementation and sustainable initiatives to document clinical evidence for select BioGX products. Serves as the subject matter expert who manages clinical performance, scientific validity, and analytical performance activities for the organization. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Clinical Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
- Directly oversees domestic & international clinical evidence activities prescribed by applicable regulatory agencies
- Provide guidance and expertise to functional areas where needed in order to continually meet evolving regulatory requirements
- Develop and maintain protocols needed to conduct scientific validations and to generate relevant clinical evidence for regulatory submissions
- Prepare written final reports containing interpretations and conclusions that are supported by results from data analysis
- Develop continuing education training materials and deliver effective training on protocols for conducting clinical studies
- Collaborate with Research & Development and Regulatory Affairs when preparing for clinical studies
- Participate in company audits and implement measurable actions necessary to achieve planned results following audits
- Adheres to good manufacturing practices and good documentation practices
- Domestic and international travel to off-site laboratories and clinical sites required
- Exercises independent judgement and decision making
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
- Ability to plan and manage complex and successful projects
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Five or more years’ experience in a US FDA-regulated manufacturing environment having clinical trials expertise
- Experience working within the framework of ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
- Experience with analyzing technical data in the area of molecular diagnostics
- Excellent written and verbal communication skills
- Must have outstanding presentation and public speaking skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
- Proficient in typing and keyboard topology
- Extremely detail-oriented with strong planning and organizational skills
- Self driven
- Able to work without supervision
Education and Experience:
- Bachelor’s Degree required; Master’s Degree or PhD preferred
Experience:
- ISO 13485 international standards: 3 years (Preferred)
- In-Vitro Diagnostic Directive (IVDD): 3 years (Preferred)
- QMS: 3 years (Preferred)
- FDA 21CFR820: 3 years (Preferred)
- US FDA-regulated manufacturing environment: 5 years (Preferred)
- In-Vitro Diagnostic Regulation (IVDR): 3 years (Preferred)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.
Job Type: Full-time
Salary: $60,000.00 – $80,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Director of Sales, Dallas
BioGX – Dallas, TX
***Send resume and include a cover letter explaining why you are the best candidate for this position.***
Purpose of the Position:
Responsible for executive leadership relative to planning and implementing sales, sales & customer support, and business partnership programs ensuring that the voices of customers and partners are heard, resulting in satisfied customers and achieving profitable revenue targets. Includes both short and long-range objectives for existing and new markets by performing the following duties personally or through subordinates.
Essential Duties and Responsibilities (other duties may be assigned):
- Reports to the Senior Vice President, Global Operations.
- Participates in key customer meetings and senior level business meetings.
- Develops and implements strategic sales plans and sales forecasts to achieve corporate objectives for products and services to achieve strategic corporate revenue and market expansion.
- Develops and manages sales, and sales & customer support operating budgets.
- Achieves satisfactory profit/loss ratio and market share in relation to industry and economic trends.
- Oversees and evaluates sales research and customer feedback. Makes recommendations to improve and adjusts to the sales strategy to meet changing customers, market, sales and competitive conditions.
- Routinely monitors competitor products, sales and marketing activities.
- Actively establishes and maintains Key Opinion Leaders (KOL) relationships and connects with industry advocates, industry influencers and key strategic partners.
- Directs sales forecasting activities and sets performance goals accordingly.
- Directs staffing, training, and performance evaluations to develop sales & customer support and sales teams to expand partner and direct sales.
- Directs sales channel development activity and coordinates sales distribution by establishing sales territories, quotas, and goals.
- Represents the Company at key trade association meetings to promote services and product.
- Meets with key partners and clients to assist sales representative with maintaining relationships and negotiating and closing deals.
- Coordinates liaison between sales departments and other sales related partners and channels.
- Analyzes and controls expenditures of division to conform to budgetary requirements.
- Prepares periodic sales reports showing sales volume, potential sales, and areas of proposed client base expansion.
- Reviews and analyzes sales performances against programs, quotas and plans to determine effectiveness.
- Directs and clarifies customer requirements and input to research and development team.
- Acts as customer’s voice for internal teams.
- Represents BioGX at trade shows, conferences and distributor partner meetings.
- At times, may require greater than 50% overnight travel.
- Work with Director, Marketing & Product Support and Innovation to ensure achievement of the strategic goals and objectives of the business products.
Supervisory Responsibilities: Supervises Sales & Customer Support Team members
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Well organized and efficient with handling multiple tasks at the same time.
- Technical supervisory experience.
- Deep Market Knowledge of Diagnostic Industry including Cancer, infectious diseases and genetics.
- Experienced and competent in assay and platform development processes.
- Sales and executive management experience. Senior marketing experience is a plus.
- Connected with industry thought leaders for rapid market development.
- Proficient Communicator skills with superior ability to present to customers, executive team and BioGX team members.
- Customer/Client/Partner Focus.
- Demonstrated Leader and coach.
- Exceptional problem solving and analytical skills.
- Proven as results driven.
- Strategic Thinkers
- Fluent in the use of Microsoft Word, Excel, PowerPoint and Google Suite.
- Excellent written and verbal communication skills.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to effectively function, manage and resolve conflicts under stressful conditions.
Education and Experience: The ideal candidate will have a Bachelor’s degree in Chemistry, Molecular Biology, Medical Technology or related field with 10 years of experience in sales, business development and strategic partnerships with progressive management experience.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Salary: $150,000.00 – $180,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Inside Sales Specialist, Dallas
BioGX – Dallas, TX
***Please include a cover letter explaining why you are the best candidate for this position.***
Purpose of the Position:
Work with customers to determine needs, create solutions and ensure a smooth front-end sales process. Uncover new sales opportunities through internet-based research, review of business directories, follow up of client referrals, and exploration of lead lists. Ultimate purpose of the position is to create incremental revenue opportunities and, where possible, convert to actual revenue.
Essential Duties and Responsibilities (other duties may be assigned):
- Identify revenue generating business opportunities using various research based methods (internet, referrals, lead lists, cold calling, triangulation, etc.)
- Source new sales opportunities through inbound lead follow-up and outbound cold calls and emails
- Understand customer needs and requirements
- Route qualified opportunities to the appropriate internal resources for further development and closure
- Close sales, where applicable, and achieve quarterly quotas
- Research accounts, identify key players and generate interest
- Maintain and expand ZoHo database of prospects
- Team with business partners to build pipeline and close deals
- Forecast sales
- Develop sales strategies to effectively generate new business opportunities and leads
- Evaluate customers needs and build productive long lasting relationships
- Meet personal and team sales targets
- Research accounts and generate or follow through sales leads
- Attend meeting, sales events and trainings to keep abreast of the latest developments
- Report and provide feedback to management using financial statistical data
- Performs duties and responsibilities as assigned by Manager
- Present, promote and sell products/services using solid arguments to existing and prospective customers
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Establish, develop and maintain positive business and customer relationships
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Achieve agreed upon sales targets and outcomes within schedule
- Coordinate sales effort with team members and other departments
- Analyze the territory/market’s potential, track sales and status reports
- Supply management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Continuously improve through feedback
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven inside sales experience
- Track record of over-achieving quota
- Strong phone presence and experience dialing dozens of calls per day
- Proficient with corporate productivity and web presentation tools
- Experience working with ZoHo, Salesforce.com or similar CRM
- Excellent verbal and written communications skills
- Strong listening and presentation skills
- Ability to multi-task, prioritize, and manage time effectively
- Familiarity with different sales techniques and pipeline management
- Computer use competency
- Strong communication, negotiation and interpersonal skills
- Self motivated and driven
- BA/BS degree or equivalent, preferably in Life Sciences
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Life Sciences. 2+ years of sales experience in healthcare industry preferred.
Language Skills: Must be proficient in writing and communicating in the English language. Multi-lingual a definite plus.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Department: Sales & Marketing
Location: Dallas
Salary: $50,000.00 – $65,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
IT Support Associate
BioGX – Birmingham, AL
Purpose of the Position: The IT Associate purpose is to provide outstanding information technology support to BioGX employees; They also perform basic internal IT functions.
Essential Duties and Responsibilities (other duties may be assigned):
- Install and configure hardware and software components.
- Repair or replace damaged hardware.
- Upgrade systems to enable compatible software.
- Install and upgrade antivirus software.
- Perform tests on new hardware and software.
- Define software, hardware and network requirements.
- Troubleshoot hardware and software issues.
- Ensure implementation of Standard IT Work Processes, Quality Assurance and Control Processes.
- Oversee management and execution of infrastructure projects for IT and facilities.
- Allocating, maintaining, and troubleshooting of IT equipment used in Amazon Operations facilities.
- Handling support requests and procedures across the network.
- Assisting in training new hires.
- Continuous learning of new technologies.
- Supporting internal local and remote users.
- Understanding of Service Management, Project Management, and Inventory Management.
- Ability to work, prioritize and make decisions independently in a fast-paced production environment.
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Expertise in basic areas of IT such as Network, Server, Storage, Cloud Computing, Communication, Security, Privacy, etc..
- Knowledge and understanding of emerging technologies.
- Excellent communication skills, including the ability to speak and write clearly and succinctly in a variety of communication settings and styles.
- Working knowledge of IT Cloud, Service Management, and Network Management.
- Proven ability to translate business requirements into solutions that map to technology capabilities.
- Proficient with Mac, Microsoft and Linux OS.
Education and Experience:
- BS or BA in a technical field, or commensurate experience
- 0-2 years of experience in the technology profession focused on IT troubleshooting and support
- A valid IT Specialist certification (Preferred)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations: Relevant to education and IT experience required. CompTIA A+, CompTIA, Network +, Cisco/CCNA, Linux, Microsoft Hardware or other IT industry standard certifications preferred.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $15.00 – $24.00
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Manager, Product Delivery
BioGX – Birmingham, AL
Job Description
Purpose of the Position: Management of Product Delivery staff by organizing and monitoring the areas of Design Transfer, Production, and Quality Control (QC). This involves coordinating with R&D scientists for all steps requiring the testing and transfer of new products to Manufacturing, overseeing production and test/validation builds and QC work-flow, maintaining quality systems compliance, planning, schedules, resources, and product QC testing for release and shipping. Assist Research and Development (R&D) scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage production build, product transfer and QC staff results by communicating job expectations; planning, monitoring, and appraising job results; coaching, training, counseling, motivating, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures.
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Work with the R&D staff to transfer developed products, managing the scale-up to transition from pilot lots to full production-scale manufacturing.
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development and product transfer problems associated with genetic tests for the presence of specific DNA and RNA sequences as required.
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product transfer for timely completion of project(s).
- Maintain current knowledge of competitive technologies, new principles and theories relevant to product R&D, product transfer, and commercialization in an ISO 13485 mfg. environment.
- Designs, prepares, dilutes, aliquots, and maintains DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
- Document product transfer protocols, results of studies and process design/development history to meet QMS requirements.
- Works with BioGX Marketing dept. to prioritize product releases.
- Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action.
- Assist in attaining quarterly and annual production goals.
- Learn and enforce company safety policies and practices.
- Manages, coordinates and executes reagent manufacturing build, product transfer and Quality Control procedures and schedules.
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures.
- Manage, plan and conduct product stability testing.
- Complies with ISO 13485 and cGMP standards.
- Support continuous quality improvement.
- Maintains staff by recruiting, selecting, orienting, and training employees; developing personal growth opportunities.
- Completes timely product delivery by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; resolving Product Delivery issues promptly.
- Maintains high quality by establishing and enforcing organization standards.
- Ensures operation of equipment by identifying problems, calling for repairs; evaluating new equipment and techniques.
- Serves as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
Supervisory Responsibilities: May supervise one or more depending upon project scope.
- Responsible for the coordination and supervision of Product Delivery staff.
- Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and coordinate training of employees; planning, assigning, and supervising work; rewarding and disciplining employees; addressing complaints and resolving personnel conflicts and problems.
- Assist in attaining quarterly and annual production goals
- Learn and enforce company safety policies and practices.
- Lead and/or support Lean Manufacturing initiatives.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Familiar with the use of Arrhenius and stability relationships to establish product stability claims.
- Direct experience with ISO design control procedures and participation in development, verification, validation stages of technology transfer into a GMP manufacturing unit.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience.
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions.
- First hand experience with medical devices manufacture (and/or biotechnology pharmaceuticals with knowledge of IVD requirements)
- Possess the skills necessary to create and lead a culture of commitment to the values vital to organizational development and growth
- Proven ability to deliver productivity to plan
- Willing to resolve problems
- Ability to collaborate and work effectively with diverse groups, incorporate the input of others to improve our processes, and align with internal customers
- Committed to developing and empowering others; to accomplish goals through the skills of persuasion, influence and negotiation
- Must have excellent communication skills (listening, written, verbal, presentation)
- Ability to interface and exchange information with all levels within the company’s workforce
- A team player that works with management and technicians to strive for continuous improvement
- Knowledge of bills of materials and other planning activities
Education and Experience: The ideal candidate will have a Ph.D. or equivalent degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to succeed in the job function.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments.
While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate. Assist Research and Development scientists in performing laboratory research as required to finalize development and product transfer to manufacturing of multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select appropriate control materials, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements. Includes design, preparation, dilution, aliquoting, and maintenance of DNA, RNA, and whole cell control materials as required for use in product transfer functions and manufacturing QC testing.
Job Type: Full-time
Salary: $60,000.00 – $70,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Manufacturing Technician
BioGX – Birmingham, AL
Purpose of the Position:
The Manufacturing Technician is responsible for general laboratory duties focused on manual and automated filling and packaging of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Manufacturing Technician is expected to follow standard operating procedures and quality systems documentation in a GMP environment.
Essential Duties and Responsibilities (other duties may be assigned):
- Coordinates and executes reagent fill and pack procedures
- Updates manufacturing batch records for manufacturing’s review
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
- Assists in process scale-up to transition from pilot lots to full production-scale reagents filling and packaging
- Assists in inventory management
- Assists in maintaining production and laboratory equipment
- Dispense and aliquot chemicals and reagents from bulk containers
- Print and apply container labels
- Performs job functions in compliance with QMS standards.
- Supports continuous quality improvement
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven ability to deliver productivity to plan
- Must have excellent communication skills (listening, written, verbal, presentation)
- Proven math skills
- Experience with Excel
- Demonstrated attention to detail
- Proven ability to meet deadlines and work under aggressive timelines
- Demonstrated ability to work effectively in a team environment
- Accurate and precise manual pipetting and measuring techniques
- Experience working with automated dispensing equipment is preferred, but not required
Education and Experience: High School degree or equivalent required. At least 2 years of hands-on experience in a GMP manufacturing environment.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time, Part-time
Pay: $12.00 – $14.50 per hour
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Marketing Coordinator, Dallas
BioGX – Dallas, TX
Purpose of the Position:
Coordinates and implements marketing and marketing communication projects through use of public relations, special events management, advertising, marketing communications and creating brand awareness. Markets products by developing and implementing marketing and advertising campaigns; tracking sales data; maintaining promotional materials inventory; planning meetings; maintaining databases; and preparing reports.
Essential Duties and Responsibilities (other duties may be assigned):
● Works closely with VP, Sales & Marketing, MDx and internal clients to facilitate production of promotional materials.
● Writes and edits promotional copy and produces marketing pieces
● Assists team members with day to day marketing tasks and coordinating marketing projects and activities as requested.
● Organizes the production of branded items such as stationery and merchandise
● Produces marketing communications, such as flyers, brochures and tradeshow related projects
● Sets up tracking systems for marketing campaigns and online activities.
● Tracks competitor activity by keeping abreast of market changes and the marketing mix used by competitors
● Assists with production of artwork, sourcing images, print buying and checking copy
● Produces clear and concise written correspondence in the form of letters and emails
● Implements marketing and advertising campaigns by assembling and analyzing sales forecasts
● Integrates Social Media into Marketing Communications
● Supports sales staff by providing sales data, market trends, forecasts, account
analyses, new product information; relaying customer services requests.
● Researches competitive products by identifying and evaluating product characteristics, market share, pricing, and advertising; maintaining research databases.
● Plans Annual Meetings by identifying, assembling, and coordinating requirements; establishing contacts; developing schedules and assignments; coordinating activities
● Updates job knowledge by participating in educational opportunities; reading trade publications.
● Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
● Travel to customer sites and tradeshows. (30%+)
● Perform duties and responsibilities as assigned by Manager.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
● Experience in marketing and marketing communications.
● Well organized and efficient with handling multiple tasks at the same time.
● Excellent written, interpersonal, verbal communication and presentation skills.
● Demonstrated ability to work as part of a multi-disciplinary team.
● Customer management and customer facing skills and attributes.
● Experience working in process development or, a Good Manufacturing Process (GMP) controlled Operations.
● Ability to handle and resolve conflicts and work under stressful conditions.
● Strong negotiating skills.
● Sound organizational and coordination skills.
● Ability and willingness to travel and work weekends.
● Proven job reliability, diligence, dedication and attention to detail.
● Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Marketing, Business or related field. 3+ years of work experience in healthcare industry. Marketing and Marketing Communications experience a bonus.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that
must be met by an employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the
essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench
or automated machine. Work may involve occasional climbing or balance. Work entails
occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation
without mechanical assistance, strength, coordination, dexterity, range of motion) must be
sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative
of those an employee encounters while performing the essential functions of this job.
Reasonable accommodations may be made to enable individuals with disabilities to perform the
essential functions.
This position will involve a combination of office and biotechnology laboratory environments.
While performing the duties of this job, the employee may be exposed to hazardous chemicals,
blood-borne pathogens, automated equipment, and high levels of noise and vibration. The
noise level in the work environment is usually moderate.
Salary: $50,000.00 – $65,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Molecular Sales Consultant, Dallas
BioGX – Dallas
Purpose of the Position: To represent our corporate services to customers and potential customers. Work with customers to create solutions and ensure a smooth sales process. Uncover new sales leads, through business directories, client referrals, tradeshow leads, cold calls, industry organizations, etc. Represent the face of our company to field based, new or existing, customers.
Essential Duties and Responsibilities (other duties may be assigned):
- Close positive revenue generating business by using various customer sales methods (cold calling, presentations etc)
- Forecast sales
- Develop sales strategies to effectively generate new business opportunities and leads
- Evaluate customers skills, needs and build productive long lasting relationships
- Meet personal and team sales targets
- Research accounts and generate or follow through sales leads
- Attend meeting, sales events and trainings to keep abreast of the latest developments
- Report and provide feedback to management using financial statistical data
- Maintain and expand client database within your assigned territory
- Performs duties and responsibilities as assigned by Manager
- Present, promote and sell products/services using solid arguments to existing and prospective customers
- Perform cost-benefit and needs analysis of existing/potential customers to meet their needs
- Establish, develop and maintain positive business and customer relationships
- Reach potential customers through cold calling
- Expedite the resolution of customer problems and complaints to maximize satisfaction
- Achieve agreed upon sales targets and outcomes within schedule
- Coordinate sales effort with team members and other departments
- Analyze the territory/market’s potential, track sales and status reports
- Supply management with reports on customer needs, problems, interests, competitive activities, and potential for new products and services.
- Keep abreast of best practices and promotional trends
- Continuously improve through feedback
- Travel to customer sites and tradeshows. (50%+)
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven sales experience
- Track record of over-achieving quota
- Experience working with CRM program
- Familiarity with different sales techniques and pipeline management
- Computer use competency
- Strong communication, negotiation and interpersonal skills
- Self motivated and driven
- BA/BS degree or equivalent
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Ability and willingness to travel and work weekends.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Life Sciences. 10+ years of sales experience in healthcare industry.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $70,000.00 – $85,000.00 per year
Product Manager
BioGX – Birmingham, AL
***A cover letter is required to inform BioGX, Inc. why you are our best candidate.***
Purpose of the Position:
To develop molecular diagnostic products by identifying product potential; conduct market research; generate product requirements; determine product specifications, production timetables, pricing, and time-integrated plans for product introduction; and develop marketing strategies.
Essential Duties and Responsibilities (other duties may be assigned):
- Determines customers’ needs and desires by specifying the research needed to obtain market information.
- Recommends the nature and scope of present and future product lines by reviewing product specifications and requirements; appraising new product ideas and/or product or packaging changes.
- Assesses market competition by comparing the company’s product to competitors’ products.
- Provides source data for product line communications by defining product marketing communication objectives.
- Obtains product market share by working with sales to develop product sales strategies.
- Assesses product market data by calling on customers with field sales people and evaluating sales call results.
- Provides information for management by preparing short-term and long-term product sales forecasts and special reports and analyses; answering questions and requests.
- Reviews inventory and product viability to assess ROI and product life.
- Brings new products to market by analyzing proposed product requirements and product development programs; preparing return-on-investment analyses; establishing time schedules with R&D and manufacturing.
- Introduces and markets new products by developing time-integrated plans with sales, advertising, and production.
- Determines product pricing by utilizing market research data; reviewing production and sales costs; anticipating volume; costing special and customized orders.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; and participating in professional societies.
- Contributes to team effort by accomplishing related results as needed.
- Performs duties and responsibilities as assigned by Manager.
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven work experience in product management.
- Proven track record of managing all aspects of a successful product throughout its lifecycle.
- Proven ability to develop product and marketing strategies and effectively communicate recommendations to executive management.
- Command of infectious disease organisms and diagnostic methodologies.
- Solid technical background with understanding and/or hands-on experience in molecular diagnostics and similar technologies.
- Strong problem solving skills and willingness to roll up one’s sleeves to get the job.
- Skilled at working effectively with cross functional teams in a matrix organization.
- Excellent written and verbal communication skills.
- MS/BS degree in Life Sciences or equivalent preferred.
- Highly skilled in product management, relationship management, people management, understanding customer needs, product development, requirements analysis, pricing, planning, competitive analysis, collaborative sales planning, understanding inventory control, financial planning and marketing strategy.
- Well organized and efficient with handling multiple tasks at the same time.
- Excellent written, interpersonal, verbal communication and presentation skills.
- Demonstrated ability to work as part of a multidisciplinary team.
- Customer management and customer facing skills and attributes.
- Experience working in process development or, a Good Manufacturing Process (GMP) controlled Operations.
- Ability to handle and resolve conflicts and work under stressful conditions.
- Sound organizational and coordination skills.
- Ability and willingness to travel and work weekends.
- Proven job reliability, diligence, dedication and attention to detail.
- Fluent in the use of Microsoft Word, Excel, PowerPoint, CRM databases, and the Google Suite (Docs, Sheets, Slides).
Education and Experience: The ideal candidate will have a Bachelor’s Degree in Marketing and/or Life Sciences. 5+ years of work experience in the healthcare industry.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Certifications, Licenses, Registrations: US Driver’s License required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working with a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Required travel: 25% (Required)
Salary: $60,000.00 – $80,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Reagent Production Associate I
BioGX – Birmingham, AL
Purpose of the Position:
The Reagent Production Associate I is responsible for general laboratory duties focused on manufacturing of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Reagent Production Associate I is expected to follow standard operating procedures and quality systems documentation.
Essential Duties and Responsibilities (other duties may be assigned):
● Coordinates and executes reagent manufacturing procedures
● Compiles and submits manufacturing batch records for manufacturing’s review and QC testing
● Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
● Assists in process scale-up to transition from pilot lots to full production-scale manufacturing
● Assists in inventory management and ordering materials
● Assists in the development of reagent manufacturing processes and documentation
● Assists in maintaining production and laboratory equipment
● Assists in the development of physical quality specifications and tests
● Assists in testing raw materials for reliability and stability
● Assists in transferring processes from development to manufacturing
● Performs job functions in compliance with QMS standards.
● Supports continuous quality improvement
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
● Proven ability to deliver productivity to plan
● Must have excellent communication skills (listening, written, verbal, presentation)
● Strong technical skills, including a working understanding of molecular biology and biochemistry
● Demonstrated analytical, troubleshooting, and problem solving skills
● Proven math skills
● Experience with Excel
● Demonstrated attention to detail
● Proven ability to meet deadlines and work under aggressive timelines
● Demonstrated ability to work effectively in a team environment
● Accurate and precise manual pipetting and measuring techniques
● Experience working with automated dispensing equipment is preferred, but not required
Education and Experience: B.S./M.S. in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Salary: $33,000.00 – $40,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Reagent QC Associate
BioGX – Birmingham, AL
Purpose of the Position:
The Reagent QC Associate is responsible for general laboratory duties focused on Quality Control of standards, controls and panels for commercially available nucleic acid tests and other advanced reagents. The Reagent QC Associate will work under the direction of the Manager, QA & Regulatory, EU and is expected to follow standard operating procedures and quality systems documentation.
Essential Duties and Responsibilities (other duties may be assigned):
- Coordinates and executes reagent manufacturing Quality Control procedures
- Compiles and submits manufacturing QC data and batch records for QA review and approval
- Maintains records and clean room environment to comply with good manufacturing practices and standard operating procedures
- Assists in inventory management and ordering materials
- Assists in the development of reagent manufacturing QC processes and documentation
- Assists in maintaining production and laboratory equipment
- Assists in the development of physical quality specifications and tests
- Assists in testing raw materials for reliability and stability
- Assist in transferring processes from development to manufacturing
- May assist in process scale-up to transition from pilot lots to full production-scale manufacturing
- Complies with ISO 13485 and cGMP standards.
- Supports continuous quality improvement
Supervisory Responsibilities: N/A
Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Proven ability to deliver productivity to plan
- Must have excellent communication skills (listening, written, verbal, presentation)
- Strong technical skills, including a working understanding of molecular biology and biochemistry
- Demonstrated analytical, troubleshooting, and problem solving skills
- Proven math skills
- Experience with Excel
- Demonstrated attention to detail
- Strong written and verbal communication skills
- Proven ability to meet deadlines and work under aggressive timelines
- Demonstrated ability to work effectively in a team environment
- Accurate and precise manual pipetting and measuring techniques
- Experience working with automated dispensing equipment is preferred, but not required
Education and Experience: B.S./M.S. in molecular biology or related field with at least 2 years of hands-on experience in reagents manufacturing.
Language Skills: Must be proficient in writing, and communicating in the English language including presenting of data and results. Computer literate with a working knowledge of Microsoft Word and Excel.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skill are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood-borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Salary: $33,000.00 – $40,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Regulatory Affairs Manager
BioGX – Birmingham, AL
***Please include a cover letter with your response that explains why you are the best candidate for this position.***
Purpose of the Position: Provides leadership, direction and support for the implementation and sustainable initiatives for domestic and international product registrations for BioGX. Serves as the subject matter expert in regulatory & international standards and exercises judgment independently. Ensures effective execution of compliance activities in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.
The Regulatory Affairs Manager will play a direct role in BioGX’s overall compliance with product registration requirements in domestic and international markets.
Essential Duties and Responsibilities:
- Directly oversees domestic & international submittals and product registrations prescribed by applicable regulatory agencies
- Serve as the Representative who interacts with domestic and international regulatory agencies
- Advises the Sr. Director of Regulatory Affairs on regulatory requirements and changes that affect other functional areas
- Provide guidance to functional areas where needed in order to continually meet evolving regulatory requirements
- Takes all reasonable and prudent measures necessary to maintain regulatory compliance with company and product registration requirements with appropriate notification to, and/or direction from, the Sr. Director, Regulatory Affairs.
- Ensure that processes needed for the quality management system are promulgated throughout the organization
- Develop and implement strategies to support/maintain certification/registrations
- Keeps abreast of changes to quality regulations, standards and guidance documents. Advise management of any business implications of these changes and lead the activities necessary to address the relevant changes
- Lead in the identification, development, implementation and continual improvement of quality systems across the organization. Oversee compliance processes and implement improvements
- Interface with FDA, Notified Bodies, and Alabama State Department of Health in the event of Company inspections. Work effectively across the organization to maintain a state of readiness for inspections by regulatory authorities and partners
- Participates in company audits with auditing authorities to ensure processes are monitored, measured and analyzed to improve or maintain the effectiveness of the QMS. Implements measurable actions necessary to achieve planned results following audits
- Adheres to good manufacturing practices and good documentation practices
- Some domestic and international travel required
- Exercises independent judgement and decision making
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned
Supervisory Responsibilities:
This position does not require supervisory responsibilities at this time.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s Degree required; Master’s Degree preferred
- Five or more years’ experience in a US FDA-regulated manufacturing environment having direct 510(k) and PMA submission expertise
- Strong knowledge of and a minimum of 5 years’ experience with ISO 13485 international standards, FDA 21CFR820, In-Vitro Diagnostic Directive (IVDD), In-Vitro Diagnostic Regulation (IVDR), and quality management systems
- Excellent written and verbal communication skills
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word/Good Docs), spreadsheet (MS Excel/Google Sheets), graphical, and file management software
- Proficient in typing and keyboard topology
- Extremely detail-oriented with strong planning and organizational skills
- Self driven
- Able to work without supervision
Education and Experience:
A diploma, certificate or other evidence of formal qualification, awarded on completion of an accredited university degree in law, medicine, engineering or another relevant scientific discipline. At least four years of professional experience in regulatory affairs in the area of medical devices.
Experience:
- FDA 21CFR820: 5 years (Required)
- In-Vitro Diagnostic Directive (IVDD),: 5 years (Required)
- ISO 13485 international: 5 years (Required)
- In-Vitro Diagnostic Regulation (IVDR): 5 years (Required)
- Regulatory Affairs: 5 years (Required)
- Quality Management Systems: 5 years (Required)
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with level of education.
Reasoning Ability: Excellent problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while sitting or standing. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and moderate levels of noise and vibration.
Job Type: Full-time
Pay: $70,000.00 – $90,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
QA Specialist Document Control
Purpose of the Position: Responsible for overall document control including creating, maintaining and developing design control documents in accordance with company procedures, managing device technical and design history files, and assisting the team by supporting regulatory requirements.
Essential Duties and Responsibilities:
- Prepare, compile, review, process and maintain regulatory submissions documents.
- Support the generation of technical documentation and compilation of technical files.
- Work with cross functional teams to ensure technical files and regulatory documentation are complete and conform to documented procedures. Ensure consistency, completeness, and adherence to standards across design projects.
- Track deliverables to ensure all required documentation is available to allow on-time submissions.
- Create final reports and memos as needed to support product storage and handling claims.
- Present design history records on demand.
- Proposes new strategies and methods to address immediate and upcoming technical issues.
- All documentation is prepared in accordance with good documentation practices (GDP) and cGMP as prescribed by the quality management system.
- Serve as the Process Owner for processes assigned by the BioGX Job Function Training Matrix and is responsible for the effective execution and relevancy of each documented process assigned.
- Perform additional tasks as assigned.
Supervisory Responsibilities: None.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Strong technical skills, including a working understanding of molecular biology and biochemistry
- Project planning
- Experience with design and document controls
- Excellent verbal and written communication skills
- Working knowledge of cGMP, ISO 13485 and other international standards
- Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software
- Extremely detail-oriented with strong organizational skills and high-quality standards
- Experience with technical writing preferred
Education and Experience: B.S./M.S. in molecular biology or related field with at least 2 years of experience working within a cGMP and ISO13485 environment preferably as a QA specialist. Equivalent combination of education and Molecular Diagnostics experience will be considered.
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Salary: $45,000.00 – $60,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Research Associate
BioGX – Birmingham, AL
Purpose of the Position: The position executes a range of molecular biology procedures, reagent preparation, bioanalytical procedures, and laboratory duties under supervision. Performs laboratory duties while maintaining associated health and safety guidelines, and is also responsible for maintaining inventory of laboratory reagents and supplies.
Essential Duties and Responsibilities (other duties may be assigned):
- Responsible for the day-to-day running of experiments and data analysis in the research and development laboratory.
- Responsible for carrying out work to company standards, including documentation, accurate record keeping, and maintaining related work schedules in order to support product development timelines.
- Prepares reagents and solutions as directed, using appropriate procedural and documentation methods, including industry standard good laboratory practices.
- Performs experiments and data analysis under supervision.
- Analyze, record, and compile experimental results and reports in laboratory notebook.
- Present results at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical issues.
- Responsible for maintaining R&D stockroom supplies and inventory.
- Implements the company’s health and safety policies and procedures.
- Interacts with other internal departments, as necessary, to plan and expedite project objectives.
- Provides scientific support to permit completion of development and technology transfer objectives for molecular diagnostics products.
Supervisory Responsibilities: None
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum 1 yr molecular biology or biochemistry laboratory experience post-B.S. degree
- First hand experience with assay formatting and development, biological sample handling, nucleic acid purification, molecular biology methods and techniques including PCR, PAGE/agarose electrophoresis
- Excellent written and oral communication skills with ability to present data and results
- Excellent skills with Microsoft Word and Excel
Education and Experience: The ideal candidate will have a B.S. degree in Chemistry, Biochemistry, Molecular biology or related field with 2 or more years of laboratory experience. Experience as Medical Laboratory Technician is desirable.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with B.S. level education
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench, or automated instrumentation. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $35,000.00 – $45,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Research and Development Manager
Full Job Description
***A cover letter must be included with your resume’ explaining why you are the best hire for this position.****
Purpose of the Position:
The primary purpose of this position is to manage Product Development functions at BioGX, Birmingham, AL. Primary responsibilities:
1) The Research and Development Manager is responsible for managing the completion of the research and development activities of new products, product enhancements, product improvements and product transfer. Evaluates the potential and practicality of products in development and relies on experience and judgment to plan and accomplish goals.
2) Working in a design control environment, provides scientific expertise, project management skills, application of knowledge of ISO13485, CE-IVDR, and FDA regulations to ensure product design and development documentation and processes adhere to BioGX standards and governing regulations.
Possesses and applies a broad knowledge of principles, practices and procedures of field. Demonstrates product and scientific content leadership with internal and external customers. Stays current on research developments and new concepts in molecular diagnostics, giving test design perspective to sales and marketing activities associated with current or new products. Experienced with ISO 13485, CE-IVDR, and FDA QA standards and Design Control functions.
Essential Duties and Responsibilities (other duties may be assigned):
- Manage the development of BioGX real time PCR products.
- Manage Research and Development staff.
- Manage ongoing Research and Development projects.
- Manage and plan future Research and Development configurations through project scheduling, resource allocation, and materials procurement.
- Manage product development from feasibility testing to product transfer using existing Design Control procedures
- Writing, reviewing, and editing of QMS processes and procedures as they relate to R&D.
- Review and approve/reject Product Transfer Documents (PTDs) for compliance with specifications, accuracy and completeness.
- Participate in and coordinate external and internal validation/clinical site studies and sample procurement activities.
- Ensure research and development activities are completed with adherence to regulatory requirements.
- Provide scientific expertise for Regulatory and Marketing and Sales activities associated with product launches.
- Ensures adherence to schedules and work plans.
- Provides tactical updates to R&D leadership.
- Communicates and collaborates cross-functionally to achieve program goals. Review and present project progress to the Sr. Dir., of Product Development.
Supervisory Responsibilities: Manage R&D scientists to achieve objectives. Manage staff growth and development.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Specialized knowledge and experience in molecular diagnostics and real-time PCR is required. Supervisory experience at junior to senior scientist levels.
- Specialized knowledge and experience in molecular diagnostics and real-time PCR is required. Supervisory experience at junior to senior scientist levels.
- Excellent verbal and written communication skills.
- Design control, product development and launch experience.
- Performance management experience.
- Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in IVD business.
- Working knowledge of cGMP and Quality Assurance systems used in IVD products.
- Practical experience with clinical investigations during research, development, and validation stages, the latter in support of impending regulatory submissions (510k, PMA, etc.).
- Demonstrated familiarity with relevant publications, patents and processes leading to such.
Education and Experience:
Ph.D. degree is required with 5 years of experience in the field, or Masters Degree with at least 10 years of direct experience working in Molecular Diagnostics area is required.
Language Skills: Must be proficient in writing, and communicating in the English language. Mathematical Skills: Must be consistent with Master’s Degree level education. Reasoning Ability: Good problem solving, judgment and decision making skills are required. Certifications, Licenses, Registrations: None required.
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $80,000.00 – $110,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
Scientist, Research and Development
BioGX – Birmingham, AL
Purpose of the Position: Perform laboratory research to develop multiplex PCR tests for a variety of real-time PCR platforms. Involves use of both automated and non-automated PCR instruments. Includes planning experiments, scientific literature research to evaluate and select target sequences of interest, analysis of data, documentation of research, and transfer of developed tests. Includes preparation of protocols, reports, and other documented information that meet QMS requirements.
Essential Duties and Responsibilities (other duties may be assigned):
- Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of development problems associated with genetic tests for the presence of specific DNA and RNA sequences.
- Supervises R&D staff, works in laboratory, participates on product transfer teams.
- Carries out design of experiments (D.O.E.) studies needed to establish robust PCR-based genetic test performance and uses experimental results to develop raw material requirements, product performance specifications, product packaging requirements, stability characteristics, and product’s manufacturing release test criteria.
- Carries out feasibility and development experiments, protocols, procedures, and report writing supporting product development for timely completion of project(s).
- Maintains current knowledge of competitive technologies, new principles and theories relevant to product R&D and commercialization.
- May train, motivate, and develop R&D staff.
- Document experimental protocols, results of studies and process design/development history to meet QMS requirements.
Supervisory Responsibilities: Supervise one or more Research Associates depending upon project scope.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Experience of nucleic acid, PCR-based diagnostic test product development experience.
- Experienced with DNA and RNA sample processing and sample stabilization procedures, and with BSL2 procedures and safe handling of human blood and fluids to obtain purified nucleic acids for use in test procedures.
- Well organized and efficient with handling multiple tasks at the same time.
- Technician supervisory experience.
- Experienced with short, intermediate and longer term project planning and clinical research.
- Fluent in the use of Microsoft Word, Excel, PowerPoint.
- Excellent written and verbal communication skills.
- Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members.
- Ability to handle and resolve conflicts and work under stressful conditions.
Education and Experience: The ideal candidate will have a Ph.D. or equivalent degree in Chemistry, Molecular Biology or related field. Additional field experience (5 to 10 years) is important to succeed in the job function. Master’s (Required)
Experience: Real-Time PCR: 1 year (Required)
Language Skills: Must be proficient in writing and communicating in the English language.
Mathematical Skills: Must be consistent with level education.
Reasoning Ability: Good problem solving, judgment and decision making skills are required.
Certifications, Licenses, Registrations: None required
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood borne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate.
Job Type: Full-time
Pay: $65,000.00 – $90,000.00 per year
Benefits:
- Insurance: Health, Dental, Life, Disability and Vision
- 401(k) with matching
- Flexible spending account
- Paid time off
