New 
Process Development and GMP Manufacturing Specialist, CICET
 Columbia University | |
 United States, New York, New York | |
 Apr 17, 2025 | |
The 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 Summary The 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. Responsibilities The 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 changes
Cell 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 operations
Documentation 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 activities in real-time using GMP-compliant systems and controlled documents, including but not limited to Batch Records, logbooks, detailed research notebooks, and electronic Batch Records
* Support investigations, deviations, Corrective Actions and Preventive Actions (CAPAs), change controls as part of continuous improvement and quality systems
* Contribute to the preparation of documentation for regulatory filings, including but not limited to Investigational New Drug (IND) applications.
Cross-functional Interactions:
* Interface with CICET QA, CICET QC and Analytics, and Facility Management teams to ensure manufacturing readiness and campaign execution.
* Review the Bill of Materials (BoM) and the availability of raw materials with Facility Management
* Collaborate with the Cell/Gene Therapy Clinical Team, Facility Management, QA, and QC on the scheduling of GMP productions to ensure timely production and release of drug products
* As directed by the Assistant Director for PD and GMP manufacturing, participate in tech transfer and readiness for Phase 1/2a clinical programs
* Support training of junior staff and sharing of best practices across teams
Additional Responsibilities:
* Participate in planning and discussion of laboratory projects and research data with the manager in a timely fashion, contribute to experimental design, and provide advice on methodology
* Collaborate with the QC and Analytics team to ensure efficient sample transfer and timely data review
* Assist in the development of PD and GMP manufacturing budget
* Contribute to the training of junior team members for research and process development related activities and cGMP related activities
* Review pertinent scientific literature and FDA guidelines Minimum Qualifications
Preferred Qualifications
Other Requirements
Equal Opportunity Employer / Disability / Veteran Columbia University is committed to the hiring of qualified local residents. | |