Analyst II, Quality Control (Bioassay)

Verve Therapeutics - Boston, MA

Full-time - Mid Level

Boston, MA

Professional, Scientific, and Technical Services

About the position

The Analyst II, Quality Control position at Verve Therapeutics involves supporting potency and tissue culture-based testing in a GMP environment. The role is crucial for evaluating the quality of raw materials, drug substances, and drug products, contributing to the preclinical studies of gene editing medicines. This position requires a strong background in scientific disciplines and experience in the pharmaceutical or biopharmaceutical industry, with a focus on quality control processes.

Responsibilities

• Perform routine potency testing for release and stability of drug substance and drug product utilizing potency software and Veeva LIMS.
• Review and approval of cGMP analytical data from test methods including mRNA expression, potency, and NGS testing platforms.
• Responsible for thawing and maintaining cell lines required for testing.
• Produce analytical master and working cell banks.
• Participate in method transfers and qualifications including protocol and report authoring.
• Perform qualification of controls, reference standards, and cell banks.
• Trend the performance of QC assay reagents, controls, and system suitability criteria.
• Troubleshoot methods by identifying areas of improvement and implementing changes through the change control process.
• Author and revise QC SOPs and test methods.
• Support OOS, OOT, investigations, deviations, change controls, and CAPAs pertaining to the QC laboratory.
• Maintain laboratory equipment and perform routine cleaning.
• Participate in internal laboratory audits.
• Interface with ARD, AD-CMC, Facilities, IT, QA, and QS.
• Receive samples and materials, apply internal labels, and maintain adequate supplies for testing.

Requirements

• B.S. degree in scientific discipline with 3+ years of relevant experience in the pharmaceutical or biopharmaceutical industry.
• 1+ years demonstrated quality experience in GMP environment preferred.
• Experience with cell culture required.
• Strong written and verbal skills.
• Ability to communicate across various cross-functional teams.
• Demonstrated problem-solving ability.
• Experience in GXP document review.
• Proficiency in Word, Excel, and other electronic Quality systems.

Benefits

• Opportunity to work in a leading clinical-stage genetic medicines company.
• Participation in a growing team focused on innovative treatments for cardiovascular disease.