Associate Director, AAV Process Development 1368870

Location: Cambridge, MA (Onsite)
Science: Gene Therapy

Therapeutic Area: Undisclosed

Job Overview: Lead an integrated process development team and play a critical role in successfully developing a robust AAV manufacturing processes for a gene therapy drug substance.

Responsibilities:

• Build and lead an integrated process development team across upstream and downstream functions for viral vector (AAV) clinical manufacturing
• Define and execute drug substance development plans that will establish suitable manufacturing processes and control strategies for clinical manufacturing
• Drive process tech transfer to internal and external manufacturing teams
• Contribute to regulatory filings and technical reports
• Mentor and develop scientists and associates to grow the team and prepare them for future roles

Qualifications:

• Ph.D. in Biomedical Engineering, Biochemistry, or a related discipline with 8+ years of relevant industrial experience, M.S. with 10+ years, or B.S with 12+ years
• Strong technical experience in scalable viral vector production encompassing cell culture and purification by chromatography and filtration
• Experience executing process development activities as part of a successful IND-enabling and clinical program
• Exposure to viral vector process analytics preferred
• Demonstrated ability to hire and develop high quality teams

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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jditalia@stratacuity