Associate Director, Drug Product

Immunovant is seeking an Associate Director, Drug Product Development to support the ongoing formulation and manufacturing of biologics drug products at their CMO partners. This role involves process scale up, technology transfer, regulatory submission preparation, and oversight of quality control and regulatory activities. The ideal candidate will have experience in drug product development and a strong understanding of process characterization and manufacturing processes.

Requirements

• B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering, Biochemistry, Microbiology, or related field with 10 or more years of relevant experience.
• Advanced degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience
• Experience with drug product process development, process characterization, technology transfer, and scale-up of biologics (mAbs or fusion proteins)
• Experience with drug product unit operations (freeze/thaw, mixing, filtration, filling, inspection).
• Working knowledge of regulatory requirements for commercialization (Quality by Design, Application of DI)
• Working knowledge of analytical methods for characterizing biologics.
• Experience with late-stage commercialization of biologics drug-device programs (PPQ and launch).
• Effective oral and written communication skills.
• Ability to articulate understanding of protein and process science to drive decision-making.

Benefits

• Medical, dental, and vision insurance
• 401k
• Parental leave
• Paid time off