CMC Analytical Scientist

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, Western blot, ELISA and Flow cytometry
• Independently plan, perform, analyze, and interpret experiments
• Prepare technical reports, study summaries, and presentation materials
• Collaborate with CMC teams to support tech transfer and CMC activities
• Drive continuous improvement by implementing new tools and technologies in CGT CMC analytics
• Ensure compliance with BSL-2 biosafety standards, cGMP, and regulatory requirements

Requirements

• Ph.D. with 2+ years or M.S. with 3+ years in Molecular Biology, Cell & Gene Therapy, Biochemistry, or related field
• Hands-on experience in lentiviral vector release testing and characterization
• Expertise in qPCR, ddPCR, ELISA, or DNA Sequencing/Analysis
• Experience with Western blotting and flow cytometry
• Working knowledge of Good Documentation Practices and ALCOA+ principles
• Strong problem-solving and communication skills

Preferred Qualifications

• Exposure to NGS-based methods for vector or genome characterization
• Familiarity with FDA and ICH regulatory requirements
• Experience with EU Annex 1 and laboratory audits

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with company match
• Paid parental leave
• Paid time off including vacation, personal, and sick time
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Commuter benefits and well-being initiatives

About the Company

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies.