Title: Biologics Analytical Development Scientist
Company Summary: A quickly growing, mid-sized phase III combination bio-tech company based in the San Francisco Bay Area is currently looking for a Biologics Analytical Development professional to join their team to help support the activities for the biologic drug product development program.
The Biologics Analytical Development professional will be responsible for...
- Supporting the development, validation, qualification, and transfer of analytical methods
- Maintaining an organized system for the tracking and archiving of GMP and non-GMP analytical and research data and documentation for successful regulatory filings
- Apply technical and management expertise to meet project goals and timeline
The Biologics Analytical Development professional should have the following qualifications...
- Masters degree in Biochemistry, Analytcial Science, or Pharmaceutical Sciences
- 5+ years of relevant industry experience in CMC
- Analytical techniques such as HPLC, SEC, CE-SDS, bioassy methods, etc.
- Knowledge of cGMP requirements and other regulatory guidelines
If interested in learning more about the role, please don't hesitate to apply as the process is moving rather quickly.