Upvote
Downvote
Senior Director Biologics Analytical Technologies
Share Job
- Suggest Revision
- We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.
- The Senior Director ensures phase-appropriate assay development requirements as programs progress through the stages of biologics drug development with a line of site towards development of assays which will be robust, reproducible and capable of being qualified and validated for GMP use, for commercial products.
- Provide scientific, regulatory, and compliance oversight to the Biologics Analytical Technologies group responsible for analytical methods developed, optimized and performed to support preclinical, phase I through phase III clinical trials including raw material testing; in process, characterization and release bulk drug substance testing; and stability study testing for BDS and DP. Also, supports Phase III/licensure by technology transfer to external partners.
- 20%) Works through and with others in the global organization, including IPTs, CMC teams, global scientific leads, and other program contributors across Eisai sites to share expertise, ensure optimum decision making, facilitate smooth information exchange, and help drive progress in biopharmaceutical programs.
- The individual may interact, sharing knowledge, expertise, and reasoned guidance, with external partners and collaborators, regulatory agencies, IPTs, and Eisai program leaders, contributors, and scientists at US, EU and Japanese sites engaged in biopharmaceutical research, development, and commercialization.
Active Job
Updated 10 days agoSimilar Job
Relevance
Active