Are you experienced in the manufacture of a cell-based product? Have you had responsibility for the business relationship management of contract manufacturing organizations or external vendors? If so, this may be your next career move!
Our client is one of the top cell & gene therapy companies in the Cambridge/Boston area. This role is with a mid-size company and they have a culture that can't be beat. Don't miss your chance to make a significant impact for patients afflicted with rare diseases and cancer.
The main function of this role is to support process and technology transfer and GMP manufacturing operations for gene therapy and manufacturing processes.
Responsibilities include but are not limited to;
• Provide management oversight for technical support of GMP manufacturing runs for ongoing clinical studies
• Work closely with QA and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
• Identify risks and drive continuous improvement in the manufacturing process and disposition
• Manage timelines and deliverables for technology transfer to CMOs including raw material and equipment procurement
• Conduct on-site or off-site training of CMO personnel
• Author, review, and approve CMC documentation for regulatory filings
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have a BS degree or higher and 5 – 10+ years of cGMP manufacturing of Phase I/II cellular and gene therapies and previous management experience. Preference given to those with tech transfer and CMO management experience and/or prior cGMP cell or gene therapy manufacturing experience for clinical-stage products.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.