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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Molecular Applications Specialist -Western Europe

Purpose of the Position: Molecular Applications Specialist serves as an internal voice of customer and partners for all BioGX products. This is a career growth position that will drive and assist with developing customer requirements, provide prompt technical issue identification and resolution, proper routing of customer support escalation. Will act as an additional product support person to manage existing and new customers as a team member with Product Support Manager.

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

Direct supervision of Product Support Manager. Participate in customer meetings and management level business meetings. Primary Overall Function and responsibilities:

Customer Projects: Tracking of customer projects internally: Collecting, clarifying and documenting customer input specifications and deliverables capturing them in BioGX’s ISO Design Control Document Process. Manage customer specification sign offs for manufacturing custom products. Interface and Voice of Customer to Research, Development, Manufacturing, Quality Customer Service and BioGX management team. Technical Support: Provide first level triage, technical support and trouble shooting along with customer complaint handling. Quality and Customer value tracking: Responsible for documenting customer feedback and implementation of customers feedback surveys. Additional Responsibilities and Details: Respond to inquiries on product offering, pricing, and availability via email, phone and/or appropriately, field site visit. Intake, triage, document and escalate more complex product related technical issues to Customer/Technical Team Support and Quality Management Team. Contribute to quality compliance through proper and concise documentation of product or technical inquiries. Maintain product knowledge and contribute to process excellence through continuous improvement efforts. Create product related documents such as package inserts marketing collateral. Develop (with Quality and Customer Service) and manage all RMA activities. Ability to travel to customer sites. (50%+)

Primary Locations (Remote / Field): Western Europe.

Job Type: Full-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.

Experienced in nucleic acid, PCR-based clinical diagnostic product development along with DNA and RNA sample processing and sample stabilization procedures. Knowledge and experience with BSL-2 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. Excellent written, interpersonal, verbal communication and presentation skills Demonstrated ability to work as part of a multi-disciplinary team. Mastery of basic manufacturing, R&D, engineering, and/or scientific theories, principles, and techniques used in biotechnology manufacturing processes. Customer management and customer facing skills and attributes. Experience working in process development or, a Good Manufacturing Process (GMP) controlled manufacturing or research environment is necessary. Ability to handle and resolve conflicts and work under stressful conditions. Fluent in the use of Microsoft Word, Excel, PowerPoint. Education and Experience: The ideal candidate will have a PhD (min of Bachelor’s Degree) in Molecular Biology, Clinical MDx or related life sciences. 3+ years of work experience in biotechnology, clinical lab or related industry.

Molecular Applications Specialist - United States

Purpose of the Position: Molecular Applications Specialist serves as an internal voice of customer and partners for all BioGX products. This is a career growth position that will drive and assist with developing customer requirements, provide prompt technical issue identification and resolution, proper routing of customer support escalation. Will act as an additional product support person to manage existing and new customers as a team member with Product Support Manager.

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

Direct supervision of Product Support Manager. Participate in customer meetings and management level business meetings. Primary Overall Function and responsibilities:

Customer Projects: Tracking of customer projects internally: Collecting, clarifying and documenting customer input specifications and deliverables capturing them in BioGX’s ISO Design Control Document Process. Manage customer specification sign offs for manufacturing custom products. Interface and Voice of Customer to Research, Development, Manufacturing, Quality Customer Service and BioGX management team. Technical Support: Provide first level triage, technical support and trouble shooting along with customer complaint handling. Quality and Customer value tracking: Responsible for documenting customer feedback and implementation of customers feedback surveys. Additional Responsibilities and Details: Respond to inquiries on product offering, pricing, and availability via email, phone and/or appropriately, field site visit. Intake, triage, document and escalate more complex product related technical issues to Customer/Technical Team Support and Quality Management Team. Contribute to quality compliance through proper and concise documentation of product or technical inquiries. Maintain product knowledge and contribute to process excellence through continuous improvement efforts. Create product related documents such as package inserts marketing collateral. Develop (with Quality and Customer Service) and manage all RMA activities. Ability to travel to customer sites. (50%+)

Primary Locations (Remote / Field): Northeast, Southeast, Midwest, Southwest, Northwest regions of the United States.

Job Type: Full-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.

Experienced in nucleic acid, PCR-based clinical diagnostic product development along with DNA and RNA sample processing and sample stabilization procedures. Knowledge and experience with BSL-2 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. Excellent written, interpersonal, verbal communication and presentation skills Demonstrated ability to work as part of a multi-disciplinary team. Mastery of basic manufacturing, R&D, engineering, and/or scientific theories, principles, and techniques used in biotechnology manufacturing processes. Customer management and customer facing skills and attributes. Experience working in process development or, a Good Manufacturing Process (GMP) controlled manufacturing or research environment is necessary. Ability to handle and resolve conflicts and work under stressful conditions. Fluent in the use of Microsoft Word, Excel, PowerPoint. Education and Experience: The ideal candidate will have a PhD (min of Bachelor’s Degree) in Molecular Biology, Clinical MDx or related life sciences. 3+ years of work experience in biotechnology, clinical lab or related industry.

Senior Scientist

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, Standard Operating Procedures and other written materials that meet Quality System (ISO and cGMP) requirements.

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

Work under the direct supervision of R&D management to achieve technical objectives within the scope of the overall project. 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 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 and 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 ISO standards and FDA QSR requirements. Supervisory Responsibilities: May supervise one or more R&D staff members depending upon project scope.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed below are representative of the knowledge, skill, and/or ability required:

Experienced with PCR-based diagnostic test product development. Experienced with DNA and RNA sample processing and sample stabilization procedures, BSL-2 procedures, 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. 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 while managing multiple projects.

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.

Job Type: Full-time

Required education: Doctorate Required experience: 5 years

Scientist

Purpose of the Position:

This position is a leading role in the development of automated nucleic acid assays to fulfill the company’s objectives. The person will assume a key collaborative role with other functional areas in the organization. In addition they may supervise staff to accomplish development goals.

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

Responsible for the day to day running of experiments in the assay development laboratory. Responsible for carrying out work to BioGX standards, documentation and accurate record keeping and maintaining related work schedules in order to support product development timelines. Perform experiments, analyze and interpret results. Troubleshoot experiments when necessary. Develop nucleic acid sample preparation methods using human specimens. Also develop reagent and control formulations, and PCR test methods. Carry out molecular biology techniques including analysis and bioanalytical methods. Represents the group’s work at meetings as required, and proposes new strategies and methods to address immediate and upcoming technical issues. Supervises assigned staff to accomplish development goals. Review and sign off experimental data entry and reports of results in laboratory notebooks. Oversee implementation of the company’s health and safety policies and procedures in their functional area. Other special project responsibilities as assigned. Document experimental protocols, results of studies and process design/development history to meet ISO standards and FDA QSR requirements. Interacts with other internal departments, as necessary, to plan and expedite project objectives. Works with key collaborators to develop and maintain project objectives. Provides support to permit completion of development and technology transfer objectives for molecular diagnostic products. Supervisory Responsibilities: May supervise assigned personnel.

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 essential molecular biology procedures and methods. Experience in experimental design, test method development and troubleshooting. Experience in working under Design Controls procedural guidelines. Computer literate with a working knowledge of Microsoft Word and Excel Excellent verbal and written communication skills Education and Experience : M.S. degree in Chemistry, Molecular Biology, Biology or related field with minimum 2 years experience in the field or B.S. degree with 5 years of experience . First hand experience with molecular biological techniques including PCR and nucleic acid analysis methods including PAGE/agarose electrophoresis procedures, UV-VIS spectroscopy, centrifugation, blood and clinical sample handling. Knowledge of the in vitro diagnostics industry is beneficial.

Job Type: Full-time Required experience: Scientist 5 years

Manufacturing Associate

Purpose of the Position:

The Manufacturing Associate 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 Manufacturing Associate will work under the direction of the Production Manager 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 procedures Compiles and submits manufacturing batch records for QC testing and QA 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 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 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 : Bachelors in Sciences 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.

Job Type: Full-time

Required education: Bachelor's Required experience: 2 years hands-on

Manufacturing Technician

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 will work under the direction of the Manufacturing Supervisor and 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 Supervisor 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 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) 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. degree in Biology or engineering field or Associate degree in a technical field required with 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 Required education: Associate Required experience: GMP Manufacturing, Packaging, Shipping: 2 years

Quality Assurance Specialist

ESSENTIAL DUTIES

Ensures effective compliance with core processes of the Quality Management System (QMS) as defined by QMS requirements and business protocols. Maintains effective communication with Purchasing personnel regarding deliveries, delivery discrepancies, and supplier performance. Reviews technical documentation to ensure effective compliance with QMS requirements and the existence of improvement opportunities. Coordinates training events and maintains training records related to QMS processes and corrective and/or preventive action activities. Assists with the maintaining of equipment and instrumentation records (i.e. PM Work Orders, Calibration Certificates, Service Reports, etc.) through utilization of established, electronic databases. Supports returned product, nonconforming and CAPA processes. Creates/Edits standard operating procedures and miscellaneous documentation as needed. Contributes to the accuracy and completeness of various quality management systems (QMS) records and other process documentation. Ensures Laboratory equipment are maintained regularly and are in good working order through the utilization of work orders. Creates/Edits equipment qualification protocols. Qualifies equipment per protocol as needed. Maintains detailed records accurately, and concurrently with procedures. Performs other duties and special projects 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.

Proven ability to deliver productivity to plan Must have excellent communication skills (listening, written, verbal, presentation) Proven math skills Intermediate and above experience with current versions of MS Excel and MS Word Demonstrates attention to detail Proven ability to meet deadlines and work under aggressive timelines Demonstrates ability to work effectively in a team environment Must exhibit the capacity to perform follow‐up activities independently when required Education and Experience: Bachelor Degree from a four‐year accredited college or university; and three or more years related experience and/or training.

Language Skills:

Must be proficient in writing, and communicating in the English language Including presenting of data and results.

Mathematical Skills:

Must be consistent with level of education.

Reasoning Ability:

Good problem solving, judgment and decision making skills are required. High degree of organizing skill, planning skill, prioritization skill. Multitasking ability.

Job Type: Full-time Required education: Bachelor's Required experience: Quality Assurance or Quality Systems: 3 years