Job Title: Director, Manufacturing Operations
Job Number: 23696
This position will be responsible for managing biologics contract manufacturing operations, including tech transfer, process scale up/optimization, and process validation for late stage clinical development and subsequent commercialization of new biopharmaceutical products. This role requires a strong scientific background, strong project management skills, experience working with/for contract manufacturing organizations (CMOs) and demonstrated ability to develop biopharmaceuticals for clinical and commercial use.
- Manage biologics contract manufacturing operations at CMOs in the US and/or Europe.
- Lead project team(s) responsible for creating and executing process development plans, including tech transfer, process scale up and optimization, and process validation activities, and developing and documenting the knowledge base needed for regulatory filings.
- Manage cGMP manufacturing supply operations supporting clinical and eventual commercial manufacturing needs, providing oversight and technical support and direction to activities at CMO facilities.
- Provide input to the development of program strategy, budgets, timelines, and process development plans.
- Ensure that technical and business requirements are managed and met.
- Act as CMC writer and/or reviewer and subject matter expert for regulatory submissions and interactions with Health Authorities
- Build and maintain strong working relationships with relevant internal and external partners, including Research and Development, Project Leadership, Technical Operations, Regulatory CMC, and Quality, as well as CMO partners, ensuring that activities are managed collaboratively, efficiently, and effectively.
- Demonstrated knowledge, experience, and successful track record in biopharmaceutical process development, process characterization, tech transfer, scale-up, and process validation.
- Sound knowledge of related aspects of pharmaceutical development and commercialization processes.
- Demonstrated experience in preparation/review of CMC sections of IND/IMPD and BLA/MAA submissions.
- Ability to operate effectively in a multi-tasking, cross-functional environment.
- Demonstrated ability for critical thinking, problem solving, and innovation.
- Excellent written and verbal communication skills.
- Capable of influencing opinion and sharing process development and scale-up best practices.
- Strong interpersonal skills.
- Excellent organizational skills with experience managing projects with team members in multiple locations.
- MS/PhD (preferred) in a relevant scientific discipline.
- 10-15 years of biopharmaceutical development experience.
- Ability to travel up to 30%.