Title: Senior Manager, Drug Product Manufacturing
Location: Greater Tristate Area
Salary: Competitive Compensation + Bonus + Excellent Benefits
I am currently partnering with a leading global CDMO that is continuing to grow their R & D efforts due to their successful and innovative approach along with their partnerships. This year they are looking to capitalizing ad grow out their formulation / drug product capabilities, and looking to bring on strong scientists that want to challenge their scientific skillset through exposure to several stages of development as well as numerous modalities.
- Lead the qualification, operation, and overall success of the clinical drug product manufacturing facility.
- Establish and maintain aseptic cGMP compliant fill/finish operations.
- Train and supervise the drug product manufacturing team for the execution of DP manufacturing processes.
- Develop, author, review, and approve SOPs/protocols for manufacturing-related activities.
- Act as Subject Matter Expert (SME) on applicable DP manufacturing equipment and procedures.
Qualifications / Requirements:
- B.S. or M.S. in Life Sciences, Engineering, or related fields with 12+ years/10 years in biopharmaceuticals or highly regulated industry
- Proven experience in drug product manufacturing with a focus on aseptic filling processes.
- Strong knowledge of Current Good Manufacturing Practices (cGMP) and biologics drug product manufacturing processes.
If interested please feel free to reach out via email or call me at (646)759-4564