Our client is seeking experienced biologics manufacturing Associates and Managers (title commensurate with experience) to work closely with external CMO partners as they commercialize their cell & gene therapy products.
Responsibilities include but are not limited to;
• Technical support of GMP manufacturing runs for ongoing clinical studies and/or commercial production carried out by external partners and CMOs
• Resolution of deviations, CAPAs, Change Controls, review of batch records, etc.
• Tracking and trending in-process data to help drive decision-making and process improvements
• Training CMO personnel and serve as person-in-plant for on-going manufacturing, process engineering, and/or training runs
• Support process improvement activities and participate in internal planning meetings with cross functional departments
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have BS degree or higher in Life Sciences or related discipline and 4+ years of industry experience in biologics, vaccines, cell therapy, or gene therapy.
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 limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.