Process Development and GMP Manufacturing Specialist, CICET

The Trustees of Columbia University in the City of New York • New York, NY • 1d ago

Job Type: Officer of Administration- Regular/Temporary: Regular- Hours Per Week: 35- Standard Work Schedule:- Salary Range: $75,000 - $95,000The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.Position SummaryThe Columbia Initiative in Cell Engineering and Therapy (CICET) Process Development (PD) and GMP Manufacturing Specialist will report to the Assistant Director of the PD and GMP Manufacturing. The PD and GMP Specialist, under the direction of the Assistant Director of the PD and GMP manufacturing, will work closely with the CICET Quality Control (QC) and Analytics team, CICET Facility Management and Operation, and CICET Quality Assurance (QA), as well as research teams, to scale up and translate the research production processes for cell and gene therapy products into a robust current Good Manufacturing Practice (cGMP) manufacturing process. The specialist will produce cell therapy drug products in a Good Manufacturing Practice (GMP) environment. The goal is to ensure the timely production of cost-effective and high-quality cell and gene therapy products for Phase 1/2a clinical trials.ResponsibilitiesThe PD and GMP Manufacturing Specialist will support the Assistant Director in PD and GMP manufacturing in the set-up and launch of the PD laboratory and GMP manufacturing facility, be responsible for the day-to-day laboratory operations and maintenance, assist in the drafting and approval of the PD and GMP manufacturing Standard Operating Procedures (SOPs) and controlled documents (e.g., batch records and logbooks), and develop and perform early stage-stage process optimization, seamless process tech transfer to GMP, and clinical-grade cell and gene therapy manufacturing appropriate for Phase 1/2a studies in a regulated cGMP environment. Additionally, this position requires strong collaboration and communication skills to effectively drive cross-functional initiatives with the CICET QA, CICET QC and Analytics, CICET Facility Management, and research laboratories.Process Development: Assist and perform scale-up and optimization of cell therapy and vector manufacturing processes using design-of-experiments (DoE) and process analytics (flow cytometry, cytotoxicity assays, VCN, etc) Perform (hands-on) experiments to scale up and optimize unit scale operations (cell selection, gene delivery (viral or non-viral; genome editing), expansion, harvest, and formulation) Perform (hands-on) experiments to scale up and optimize unit scale operations for vector manufacturing Maintain the PD laboratory, including reagents and equipment, to ensure efficient day-to-day operations In collaboration with CICET QA, CICET QC and Analytics, and CICET Facility Management, evaluate new equipment, raw materials, and process changesCell and Gene Therapy and Vector Manufacturing (GMP): Execute GMP manufacturing of cell therapy (e.g., CAR-T and others) products, including T-cell isolation, activation, gene delivery (viral or non-viral; genome editing), expansion, harvesting, and formulation Perform viral vector (e.g., retroviral, lentiviral, or AAV) production in adherent and/or suspension platforms, including upstream (cell culture, transfection) and downstream (clarification, purification, formulation) steps Plasmid DNA or ssDNA production Maintain compliance with cGMP, aseptic techniques, and cleanroom protocols Collaborate with Facility Management to ensure efficient day-to-day GMP operationsDocumentation and Compliance: Support the drafting, reviewing, and updating of SOPs, specifications, regulatory filings, or other controlled documents in collaboration with the QA team Accurately document batch activit

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