Cedent Consulting
Principal Scientist, Late Stage Upstream Process Development
Cedent Consulting - San Francisco, California, United States, 94199
Work at Cedent Consulting
Overview
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Overview
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
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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
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