Manager, Gene Delivery & Editing Process Development

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Position Summary:

We are seeking an enthusiastic, self-driven individual to join the Gene Delivery & Editing Process Development team. Our team develops the end-to-end processes and technologies to deliver the critical raw materials used in the manufacturing of engineered T cells, including viral vectors. This team member will play a key role in the tech transfer and support of clinical manufacturing (up to process performance qualification (PPQ)) of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors, and cell lines. The ideal candidate will have experience with process development and/or early-stage clinical manufacturing including proficiency in supporting tech transfers, deviations, change controls, and OOS investigations. Hands on experience operating production processes in a manufacturing environment is desirable.

Key Responsibilities:

• Lead process and technology transfers, change management, and technical process support for successful clinical stage manufacturing of gene-delivery raw materials such as: DNA, RNA, Enzymes, RNPs, viral vectors and cell lines.
• Monitor internal and external clinical manufacturing up to process performance qualification (PPQ), identifying and managing implementation of process improvements and change controls, managing process deviations and out of specification investigations through approved quality systems for manufacturing of gene‑delivery raw materials
• Visit internal and external manufacturing sites as needed to support OOS investigations, tech transfer activities, and regulatory inspections
• Develop, implement, and optimize early-stage tech transfer plan to streamline transition from PD to clinical manufacturing teams
• Identify technical gaps in the form of risk assessments and work with PD colleagues to de-risk tech transfer, scale up/scale down and improve clinical vector processes throughout the clinical development period
• Conduct due diligence to assess onboarding of new gene-delivery vendors
• Author manufacturing and process development sections of regulatory filings as well as technical documents suitable for presentation to regulatory authorities
• Up to 25% travel

Education & Experience:

• PhD. (entry level), M.S. with 3+ years of experience or B.S. with 5+ years of experience in process development or commercial manufacturing  
• Experience in a biotechnology process development or manufacturing environment for globally regulated products, such as cell & gene therapies, vaccines, or biologics
• Experience with PD and/or early-stage clinical manufacturing with experience in managing process development, tech transfers, Deviations and OOS investigations.
• Experience writing and reviewing GMP documentation
• Experience using statistical software (ex. JMP) for analysis of process and manufacturing data
• Experience with cGMP and ICH guidelines
• Proven ability to work in a fast-paced, multi-product, matrixed envir