Job Summary:

We are seeking a highly skilled Scientist to lead analytical method development, validation, and transfer for a Quality Control team. This role will focus on PCR-based and biomolecular testing, as well as cell line development (CLD) for biologics. The ideal candidate will be responsible for executing and optimizing analytical techniques, supporting regulatory compliance, and collaborating across departments to drive innovation and efficiency.

Key Responsibilities:

• Lead PCR-based method development, transfer, and validation within the QC laboratory.
• Perform biomolecular assays including qPCR, ELISA, HPLC/UPLC, CE, and SDS-PAGE for protein and pDNA characterization.
• Drive cell line development (CLD) projects, including transfection, selection, and stable CHO/HEK293 cell line generation.
• Partner with Upstream Process Development and R&D teams to enhance cell culture processes.
• Author and review method validation protocols, SOPs, reports, and regulatory documentation.
• Troubleshoot complex analytical issues and provide technical guidance to laboratory analysts.
• Support regulatory audits, quality investigations, and technology transfers.
• Source, qualify, and maintain analytical equipment to expand QC laboratory capabilities.

Qualifications:

• Ph.D. or M.S. in Biotechnology, Biochemistry, Cell Biology, or a related field.
• 1+ years (Ph.D.) or 3+ years (M.S.) of industry experience in analytical method development and cell line development (CDMO experience preferred).
• Expertise in PCR methodologies, protein characterization, and bioanalytical techniques.
• Experience with GMP, ICH, and FDA/EMA regulatory compliance.
• Strong data analysis skills, including statistical interpretation and trending.
• Ability to work in a fast-paced, cross-functional environment with minimal supervision.

Why Join?

• Be at the forefront of biopharmaceutical innovation in method validation and cell line development.
• Work in a state-of-the-art laboratory with cutting-edge analytical and cell culture technologies.
• Collaborate with industry-leading scientists and contribute to life-saving therapeutics.

If you are a motivated scientist with expertise in analytical validation and CLD, we encourage you to apply!

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