What are the responsibilities and job description for the Process Development and GMP Manufacturing Specialist, CICET position at Columbia University Irving Medical Center?
Grade 104
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
Columbia University is committed to the hiring of qualified local residents.
- Job Type: Officer of Administration
- Regular/Temporary: Regular
- Hours Per Week: 35
- Standard Work Schedule:
- Salary Range: $75,000 - $95,000
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
- 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
- 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.
- 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
- 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
- Bachelor’s degree in Biology, Biotechnology, Cell Biology, Biochemistry, Bioengineering, or a related field or equivalent in education and experience
- Minimum of 3 years of hands-on experience in CAR-T or viral vector process development and/or GMP cell manufacturing
- Strong understanding of CAR-T operations (e.g., T-cell handling, transduction, expansion, and cryopreservation) and vector production platforms
- Basic knowledge of clean room operations
- Experience in early-phase clinical manufacturing (Phase 1/2) and associated regulatory requirements
- Familiarity with single-use systems, closed manufacturing processes, and cell therapy automation platforms
- Ability to work independently to complete tasks and collaboratively with multiple teams to execute CICET strategic activities
- Strong analytical and problem-solving skills with a detail-oriented approach
- Excellent organizational skills and ability to manage multiple priorities
- Strong interpersonal and communication skills (written/ verbal)
- Working knowledge of computer programs, such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, Zoom, and data analysis software
- Ability to set priorities and exercise sound judgment and initiative
- Ability to work in a fast-paced environment with a positive attitude
- Must possess the ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution
- Ability to interact and collaborate positively, constructively, and effectively with multiple stakeholders
- 5 years of hands-on experience in CAR-T or viral vector process development and/or GMP cell manufacturing
- Experience with cell therapy analytical methods (e.g., flow cytometry, cell counting, qPCR)
- Master’s degree in relevant scientific discipline or certification in data analytics or related data analysis education, including statistics
- Knowledge of regulatory expectations related to advanced therapy medicinal products (ATMPs)
- Prior involvement in facility start-up, equipment qualification, or tech transfer projects
- Familiarity with Quality Management Systems for drafting and reviewing SOPs and Batch Records
- Position is considered essential during campus/operational emergencies
Columbia University is committed to the hiring of qualified local residents.
Salary : $75,000 - $95,000
