The Sr. Development Engineer will be a key contributor within a group responsible for performing purification process development, including small-scale experiments, scale-up, technology transfer and support for programs that bring new bio-pharmaceutical products to pre-clinical, clinical and commercial manufacturing phases.
- Will be a leading contributor during execution of purification activities for the department, including troubleshooting problems, analyzing data and authoring technical reports and memos.
- Will lead internally developed programs
- Will effectively manage external programs through contract-based organizations (CMOs, CROs and CDMOs)
- Will design and carry out experiments for purification process development, optimization and characterization studies for therapeutic proteins. The scope includes IND- and BLA-enabling studies and preparation of regulatory submissions.
- The experimental studies involve both lab scale and pilot pla