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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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.

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.

Reagent Production Technician I

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

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.

Research Associate

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.

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.

Reagent QC Associate

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

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 .

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 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