Process Scientist/Engineer, 1044479
Job Scope and Purpose:
Our Cambridge based client, focused on revolutionary stem cell-based therapies in rare disease, is seeking a CMC Process Scientist to join its expanding team. The ideal candidate will focus on late stage process development and improvements for its lead program, including stem cell culture, differentiation and downstream processing. This individual will also work with cross-functionally with the research and early stage process development teams, and the company's internal and external manufacturing teams/partners for the manufacture of our client's first cell-therapy product. For more information, reach out to Kevin Rees or Todd Jamison.
Primary Job Responsibilities:
• Oversee the design and execution of cell culture studies, with a focus on optimizing processes for the manufacturing of pluripotent stem cells
• Coordinate experiments and work collaboratively on projects with process development, manufacturing, and quality teams within the organization
• Support technology transfer, including person-in-plant responsibilities as needed at manufacturing facilities
• Perform late stage scale, characterization and investigational work, and design experiments for stability studies
• Author and maintain detailed documentation records
• Author reports, SOPs, batch records and other materials to facilitate tech transfer, manufacturing and regulatory submissions
• Lead investigations in OOS and deviations, and implement CAPAs
Primary Job Requirements:
• PhD in biology, bioengineering, process science or applicable field with at least two years or relevant process development or manufacturing experience, or MS in an applicable field with at seven years of relevant experience
• Experience with 2D and 3D cell culture, and in managing junior team members (directly or indirectly)
• Experience with cell therapy product development and in a GMP-compliant environment required
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