The ideal candidate will take on the following tasks:
- Support tech transfer and scale-up of products and processes to ensure smooth transition from process development into cGMP manufacturing.
- Assist with process-related issues and investigations.
- Participate in start-up efforts of new equipment and processes in manufacturing.
- Assist in documenting updates to manufacturing processes and working with manufacturing, engineering and validation.
- Provide technical support on project deliverables.
- Work with Quality to ensure a compliant manufacturing environment.
- BS degree and experience in biopharma based GMP manufacturing operations including direct experience in aseptic fill
- Strong technical writing ability
- Proven ability to effectively participate on teams