The individual will be responsible to manage and lead technical issue resolution relating to biologics products or key major technical projects within External Operations with minimal oversight. The individual will be responsible for external production (clinical & commercial manufacturing) of drug product including process design, optimization, scale-up, technology transfer and validation. Lead scale-up, technology transfer and production start-up activities. Includes onsite presence at our contract manufacturing organizations Support ongoing Drug Product manufacturing operations through process monitoring, trending and issue resolution. Identify and remediate risks. Drive process and program improvements through Change Controls, Investigations and Corrective Actions. Support regulatory filing updates.
- Strong understanding of technical/scientific challenges as those apply to the production processes in both Drug Substance and Drug Product Manufacture
- Working knowledge of aseptic manufacturing operations, and/or drug product manufacturing with experience with lyophilization.
- The candidate also needs to have an excellent knowledge of CMC regulations, cGMP, sterility assurance techniques and FDA guidances
- Experience with technical transfer and validation of biologic manufacturing processes.
- Demonstrated understanding of the connection between compliance and manufacturing.
- Creating business proposals, statements of work and other business agreements
- Experience within a CMC team preferred