CMC Analytical Scientist

About the role

The CMCA Analytical Scientist will support the set-up, development and maintenance of a GMP QC-Analytics Lab. They will generate and characterize engineered cell lines, develop, optimize, and execute molecular and cellular assays, and prepare technical reports and presentations. This role requires a strong background in molecular biology, cell and gene therapy, and hands-on experience with various assays and technologies.

Responsibilities

• Support the set-up, development and maintenance of a GMP QC-Analytics Lab
• Generate and characterize engineered cell lines, including production of MCB and WCB for cell-based assay development
• Develop, optimize, and execute molecular and cellular assays to assess vector performance using qPCR/ddPCR based assay, Western blot, ELISA and Flow cytometry
• Independently plan, perform, analyze, and interpret experiments, present clear data summaries and recommendations to cross-functional teams and clients
• Prepare technical reports, study summaries, and presentation materials to support decision-making
• Collaborate closely with other teams in CMC and coordinate cross-functional activities to support tech transfer and CMC activities
• Drive continuous improvement by identifying and implementing new tools, technologies, and best practices in CGT CMC analytics
• Ensure compliance with BSL-2 biosafety standards, cGMP, and applicable regulatory requirements

Qualifications

• Ph.D. with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field
• Demonstrated hands-on experience in lentiviral vector release testing and characterization (required)
• Expertise in molecular and cell biology techniques, including qPCR, ddPCR, ELISA or DNA Sequencing/Analysis
• Hands-on experience with Western blotting and flow cytometry for protein and cell-based analyses
• Exposure to NGS-based methods for vector or genome characterization is a plus
• Working knowledge of Good Documentation Practices, data integrity, and ALCOA+ principles
• Strong problem-solving skills with the ability to work independently and collaboratively in a team environment
• Excellent interpersonal, verbal, and written communication skills
• Familiarity with regulatory requirements and guidance from agencies such as FDA and ICH; experience with EU Annex 1 and laboratory audits is a plus

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with a company match that vests fully on day one
• Paid parental leave after just three (3) months of employment
• A paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Legal assistance
• Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
• Commuter benefits
• Well-being initiatives
• Peer-to-peer recognition programs

Pay

The pay range is estimated between $80k - $110k based on skill set and experience.