Careers


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.

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Manager, Quality Management Systems

Purpose of the Position: Manages core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”. Uses discretion and independent judgment to fulfill essential duties & responsibilities outlined below.

Essential Duties and Responsibilities:

● Responsible for assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, supplier performance management, corrective action, preventive action, training management, device & equipment maintenance management and performance monitoring activities required to maintain compliance to QMS requirements.

● Manages supplier management activities to including supplier selection, evaluation, and re-evaluation. Monitors processes involving the evaluation of purchased components and the dispositioning of purchased components found to be nonconforming in accordance with QMS requirements.

● Manages approved supplier lists (ASL) and approved material lists (AML).

● Manages document control and procedure development processes in accordance with QMS requirements.

● Manages corrective and preventive action processes in accordance with QMS requirements.

● Manages equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements.

● Manages equipment qualification processes to include IQ/OQ/PQ activities in accordance with QMS requirements.

● Manages compliance monitoring activities to include environmental monitoring, material evaluation and acceptance, product evaluation and acceptance, receipt and dispositioning of nonconforming material/product, equipment maintenance and calibration, equipment qualification, material and product traceability, material and product identification, risk mitigation, supplier performance monitoring, product realization, record control including good documentation practices and other BioGX processes.

● Assists with employee qualifications and training management to include on-the-job training (OJT) requirements, job descriptions, and training requirements and frequency by job function.

● Assists with risk management processes and supporting activities.

● Assists with reviewing and reporting QMS performance objectives and supporting activities.

● Assists with QMS auditing processes and supporting activities.

● Assists with risk management processes and supporting activities.

● Monitors product quality processes to ensure their continuing suitability, adequacy and effectiveness. Ensures quality processes are measured and analyzed to improve or maintain their effectiveness. Implements actions necessary to achieve planned results while ensuring the integrity of the QMS is maintained.

● Monitors and reports on key performance indicators with regards to quality processes to identify the need for corrective and preventive action.

● Ensures that processes needed for the quality management system are implemented and maintained in accordance with requirements. Develops and implements strategies to support/maintain compliance to QMS requirements.

● Alternative 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.

● Serves as a supporting liaison with auditing authorities to ensure processes are monitored, measured and analyzed to improve or maintain the effectiveness of the QMS. Carries out measureable actions necessary to achieve planned results following audits.

● Promotes the awareness of customer requirements. Echoes the importance of meeting customer, statutory and regulatory requirements.

● Participates in the regular review of quality objectives and identifies the need for corrective and preventive action.

● Brings together staff of different disciplines and drives the group to plan, formulate and agree on comprehensive quality procedures. Communicates with other company personnel to coordinate operations and activities.

● Maintains relative operations data and prepares productivity/quality feedback for management. Analyzes performance data to improve or maintain desired levels of quality. Recommends actions necessary to achieve desired level of quality as needed.

● Other duties as assigned.

Supervisory Responsibilities:

Directs and manages subordinate employees working within the department of Quality & Regulatory Affairs as 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.

● Excellent verbal and written communication skills

● Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry.

● Working knowledge of cGMP, international standards, and Quality Assurance systems.

● Medical Device industry experience

● Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software.

● Proficient in typing and keyboard topology.

● Extremely detail-oriented with strong organizational skills and high quality standards

Education and Experience: Bachelor of Science Degree from a four-year accredited college or university; or five or more years related experience and/or training.

Language Skills: Must be proficient in writing, and communicating in the English language.

Product Manager, OSR

Purpose of the Position: To develop corporate 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 salespeople 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; participating in professional societies. Contributes to team effort by accomplishing related results as needed. Performs 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.

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 Solid technical background with understanding and/or hands-on experience in molecular 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 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. 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 healthcare industry.

Language Skills: Must be proficient in writing and communicating in the English language.

Quality Assurance Specialist

Purpose of the Position: Administers/Supports/Facilitates core processes of the Quality Management System (QMS) in accordance with international standards, regulatory requirements, customer requirements, and BioGX’s standard operating procedures herein referred to as “QMS requirements”.

Essential Duties and Responsibilities (other duties may be assigned):

Administers/Supports/Facilitates assigned quality related activities within the organization, including but not limited to the maintenance of BioGX’s QMS, supplier performance management, corrective action, preventive action, training management, device & equipment maintenance management and performance monitoring activities required to maintain compliance to QMS requirements. Administers/Supports/Facilitates supplier management activities, including supplier selection, evaluation, and re-evaluation. Monitors processes involving the evaluation of purchased components and the dispositioning of purchased components found to be nonconforming in accordance with QMS requirements. Administers/Supports/Facilitates approved supplier lists (ASL) and approved material lists (AML). Data updating; Review regularly for suitability and accuracy; Self-assessment, survey, nondisclosure agreements (NDA), quality plan agreements (QPA) distribution and follow-up; Update ASL as directed; Process supplier corrective action (SCAR) requests; Maintain supplier related databases and records as assigned Administers/Supports/Facilitates document control and procedure development processes in accordance with QMS requirements. Administers/Supports/Facilitates corrective and preventive action processes in accordance with QMS requirements. Follow-ups through completion; Effectiveness checks Administers/Supports/Facilitates equipment management processes to include preventive maintenance and calibration activities in accordance with QMS requirements. Administers/Supports/Facilitates compliance monitoring activities to include environmental monitoring, material evaluation and acceptance, product evaluation and acceptance, receipt and disposition of nonconforming material/product, equipment maintenance and calibration, equipment qualification, material and product traceability, material and product identification, risk mitigation, supplier performance monitoring, product realization, record control including good documentation practices and other BioGX processes. Administers/Supports/Facilitates with risk management processes and supporting activities. Administers/Supports/Facilitates with reviewing and reporting QMS performance objectives and supporting activities. Administers/Supports/Facilitates with QMS auditing processes and supporting activities. Maintains audit related records Ensures all QMS records are complete, legible, protected and retrievable. Other duties as 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.

Excellent verbal and written communication skills Interdisciplinary team building experience involving scientists, engineers, quality assurance, manufacturing, marketing and other participants in the medical device industry. Working knowledge of cGMP, international standards, and Quality Assurance systems. Strong computer skills having advanced knowledge and experience with current word processing (MS Word), spreadsheet (MS Excel), graphical, and file management software. Proficient in typing and keyboard topology. Extremely detail-oriented with strong organizational skills and high-quality standards

Education and Experience: Bachelor of Science Degree from a four-year accredited college or university; or two or more years related experience and/or training.

Language Skills: Must be proficient in writing, and communicating in the English language.

Reagent QC Associate I

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

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.

Scientist, Reagent Manufacturing

Purpose of the Position: The Reagents Manufacturing Scientist 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 Reagents Manufacturing, Scientist is expected to follow standard operating procedures and quality systems documentation. This position also supports company goals in product development, quality improvement, collaborative projects, technical writing, and process efficiency by relying on extensive experience and expertise in these areas.

Essential Duties and Responsibilities (other duties may be assigned): Work under the direct supervision to achieve technical and quality objectives.
Uses chemistry, biochemistry, and molecular biology knowledge to solve the range of problems associated with molecular tests on diverse platforms. 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. Present results at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical issues. Interacts with other internal departments, as necessary, to plan and expedite project objectives. 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 transferring processes from development to manufacturing. Performs job functions in compliance with QMS standards. Performs additional tasks as assigned.

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. Experience translating development product designs into manufactured products Knowledge and/or experience with genetic technologies, gene amplification Project planning Experience with design controls Excellent written and verbal communication skills, including SOP and specification documents and technical report writing

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.

Scientist, Research and Development

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.

Language Skills: Must be proficient in writing and communicating in the English language