Associate Director, Genomic Medicine Purification Process Development

Role Summary

Associate Director, Genomic Medicine Purification Process Development. Location: Waltham, MA. Work Model: M-F onsite.

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 first/primary point of contact for familiarization and staying current with CDMO technical capabilities and limitations, including but not limited to equipment, instrumentation, facility, process fit, and engineering design
• Execute and improve the established standard ways of working and harmonize TT practices across programs and CDMOs. Examples of standard work include creating templates for TT risk and gap assessments, process descriptions, etc.
• Closely collaborate and stay current with internal process development to ensure external transfer is aligned with internal development efforts, and vice versa. Advise where studies or changes are required to address gaps
• Actively engaged with internal pilot scale up labs to identify operation gaps and streamline ways of working and actively participate in the execution of internal pilot batches
• Actively participate internal and external project teams and subteams 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

• PhD degree in Biotechnology, Cell Biology, Biochemistry, Chemistry, Chemical Engineering or related discipline with a minimum of 8 years of relevant industry experience or a Master’s degree with a minimum of 10 years of industry experience or a Bachelor’s degree with a minimum of 12 years of relevant industry experience
• Background specializing in Technology Transfers and new product introductions to GMP facilities
• Strong technical background in AAV purification process
• Experience with AAV cGMP Manufacturing, especially in purification operations
• Experience of engaging external CDMOs within the biopharmaceutical industry

Skills

• GMP manufacturing expertise
• Technology transfer and CDMO engagement
• Viral vector purification process knowledge
• Project management and cross-functional collaboration

Education

• PhD/Master/Bachelor in relevant field as specified in qualifications