This individual will oversee the development, monitoring and evaluation of activities in the virtual manufacturing environment, including the design of scalable manufacturing processes, the review and monitoring of process tech transfer, the collaborative development and management of test methods and release specifications. He or she will provide guidance within cross-functional teams for CMC submissions and regulatory and partner interactions.
Minimum requirements include:
- D. or eq in biology
- Experience with microbial expression, purification and protein folding
- Experience with protein Lyo-formulations
- Experience on cross-functional teams preparing regulatory submissions
- Experience with peptide is desirable