Associate Director, Genomic Medicine Purification Process Development

Role Summary

The Associate Director, Genomic Medicine Purification Process Development leads the development of robust, scalable viral vector purification processes for Sanofi’s genomic medicine pipeline. Located in Waltham, MA, the role focuses on GMP manufacturing and technology transfer to external and internal manufacturing sites, with responsibilities spanning process development, scale-up, and regulatory filing support.

Responsibilities

• Have extensive knowledge of GMP manufacturing and technology transfer to manufacturing sites
• Make strong technical and strategic contributions to cross functional project teams
• Subject matter expert for executing technology transfers to external CDMOs
• Act as the primary point of contact for CDMO familiarity with capabilities and limitations, including equipment, instrumentation, facility, process fit, and engineering design
• Execute and improve established standard ways of working and harmonize TT practices across programs and CDMOs
• Collaborate with internal process development to ensure external transfer aligns with internal development efforts and advise on necessary studies or changes
• Engage with internal pilot scale up labs to identify operation gaps and participate in internal pilot batches
• Participate in internal and external project teams to enable the above responsibilities
• Serve as a primary representative for Person-in-Plant (PiP) responsibilities to oversee CDMO activities during GMP runs
• Requires the ability to travel more than 20% of the time

Qualifications

• Required: PhD in Biotechnology, Cell Biology, Biochemistry, Chemistry, Chemical Engineering or related; or Master’s with 10+ years of industry experience; or Bachelor’s with 12+ years of industry experience
• Required: Background in Technology Transfers and new product introductions to GMP facilities
• Required: Strong technical background in AAV purification process
• Required: Experience with AAV cGMP Manufacturing, especially purification operations
• Required: Experience engaging external CDMOs within the biopharmaceutical industry

Education

• PhD degree or equivalent in a relevant field (as noted above) with extensive industry experience, or Master’s/Bachelor’s with corresponding years of experience as stated