This position will provide technical support for developing our Drug Product (primary container, filling, packaging) and selecting our Supplier/CMO to ensure successful approval, cGMP production, and technology transfer to the commercial organization
Essential Duties and Job Functions:
- Collaborate with other functions (devices, regulatory, quality, ….) to ensure requirements for our primary containers and fill/finish processes are well defined, formalized, and implemented.
- Serve as Primary container/DP expert representative on multidisciplinary CMC teams
- Design and coordinate studies with contract labs as well as review and analyze analytical and device functionality data to support development activities for primary containers and drug product process
- Lead fill/finish equipment selection and qualification as well as process design and validation at our CMOs
- Manage internal meetings and timelines from incep