Job Summary
A clinical and scientific staffing company is seeking a Remote Biologics Upstream Technical Operations Consultant Associate Director.
Core Responsibilities of this position include:
- Leading Upstream cell culture process characterization
- Partnering with internal resources and external CMOs to drive process characterization and validation
- Leading author for applicable CMC modules in BLA submission
Skills and Requirements Include:
- Extensive experience with Upstream and Downstream operations
- Excellence in breadth and depth across engineering disciplines
- Proficient in Stage 1, Stage 2, Stage 3 biologics validation
- Demonstrates in-depth knowledge of current Good Manufacturing Practices
- B.S./M.S./PhD. in Pharmaceutical Sciences, Chemical Engineering, Bioengineering, or related field
- 10+ years of relevant experience in the pharmaceutical industry and a BS or BA