Principal Scientist, Late Stage Upstream Process Development

Client is seeking an experienced and driven scientist / engineer to lead late-stage upstream cell culture process development activities for clinical and commercial-stage large molecule programs. This individual will serve as the upstream lead for scale-up and tech transfer to manufacturing sites, establishing process validation (PV) strategy and PPQ / post-approval process support.

Key Accountabilities / Core Job Responsibilities

• Lead scale-up and tech transfer of the upstream process to manufacturing sites, ensuring alignment with control strategy and regulatory filings.
• Serve as the technical lead, responsible for upstream process activities for a late-stage large molecule programs including commercial manufacturing support
• Author and review relevant CMC documentation including PV protocols / reports and regulatory sections (e.g., BLA, IND amendments).
• Develop and execute strategies for process performance qualification (PPQ) and continued process verification (CPV).
• Collaborate cross-functionally with MSAT, Downstream, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers
• Represent upstream function in regulatory strategy, technical meetings, and CDMO interactions.
• Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments etc.

Qualifications / Skills

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