Job Description
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 - PhD in biology, biochemistry, chemical engineering or related scientific discipline with minimum 7 years of cell culture process development experience in the biotech/biopharma industry; or BS/MS with 12+ years of experience.
- In-depth understanding of CHO-based fed-batch processes, scale-up/scale-down principles, and statistical tools.
- Thorough understanding of cell culture bioreactors including microbioreactors, bench-scale and pilot-scale bioreactors, and scaleup/tech transfer activities
- Demonstrated experience with late-stage upstream process development, PPQ strategy, tech transfer and BLA authoring
- Strong knowledge of regulatory expectations for process validation and control strategies.
- Excellent communication, leadership, and cross-functional collaboration skills.
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving
- Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus
- Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills
Job Tags
Contract work,