Process development from preclinical to commercialization
This role involves setting the manufacturing strategy and overseeing all process development activities from preclinical stages through commercialization for the AZ portfolio
Job Summary
This role involves setting the manufacturing strategy and overseeing all process development activities from preclinical stages through commercialization for the AZ portfolio.
The successful candidate will manage internal staff and external Contract Development & Manufacturing Organizations (CDMOs) to ensure compliance with cGMP, ICH, and FDA regulations.
AstraZeneca offers a great working atmosphere with benefits including medical insurance, annual bonuses, education cost reimbursement, and flexible working hours.
Matching Summary
This role involves setting the manufacturing strategy and overseeing all process development activities from preclinical stages through commercialization for the AZ portfolio.
Salary
Base: $148,893.60 - $223,340.40 Annual USD; Bonus/Equity: Eligible for short-term incentive bonuses and equity-based awards; Benefits: Qualified retirement programs, paid time off, health/dental/vision coverage
Skills & Requirements
Must-have
cGMP Manufacturing experience in small molecules
Management of US and international CRO/CDMOs
Process development from preclinical to commercialization
Strong background in GMP manufacturing and vendor management
Nice-to-have
Experience with biologics and antibody drug conjugates
Ability to thrive in a fast-paced startup environment
Strong interpersonal skills for cross-functional collaboration
Willingness to work as a technical subject matter expert
Key Requirements
PhD or MS with 10+ years of experience
Advanced degree in Biochemistry, Pharmaceutical Chemistry, or Chemical Engineering
Proven track record leveraging CRO/CDMOs for cGMP APIs and DP