（Sr.) Scientist, Analytical Development

Job Scope:

The position reports to the Sr. QC Manager, is ideally suited for a professional with extensive technical knowledge, and a proven track record of developing and carrying out processes, that are suitable for use in GMP manufacturing of a wide range of clinical trial materials and participating in the technology transfer.  There is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects that transform the lives of patients.

Responsibilities:

• Support the set-up, development and optimization of 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.
• May travel up to 10% to support CDMO projects or business development activities.

Qualifications:

• PHD 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.

Compensation: The salary range, dependent upon experience level, is $90,000 - $120,000 annually. 

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