Lead a small group responsible for process transfer and support on several different customer projects. Need to have experience supporting at-scale upstream processing.
- Provides technical guidance to subordinates and aids in issue resolution. Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.
- Reviews process changes and assesses change controls for impact of process / equipment or procedural changes that can affect both process performance and product quality.
- Assesses all major deviations including those that impact product quality as well as post lot release deviations that may impact multiple products.
- Performs process fit assessments for new processes.
- Supports documentation preparation for regulatory purposes.
- Bachelor of Science degree in Biological Sciences or Biomedical/Chemical Engineering.
- Extensive experience (10+yrs) in biotech industry in process development and process scale up / manufacturing.
- Substantial experience with large-scale manufacturing support (mammalian preferred), current Good Manufacturing Practices, US / EU regulations.
- Technical understanding of upstream unit operations: aseptic technique; mammalian cell culture; and harvest activities.