Overview In this role you drive analytical development within a multidisciplinary CMC team to enable regulatory filings and progress multiple clinical therapeutics. You apply a broad set of analytical techniques to support process development and characterization of biologics, contributing to a reliable pipeline and high-quality products. You will present data and collaborate across teams in a fast-paced environment, shaping analytic strategies for IND/BLA activities. This position offers growth in a mission-driven company advancing patient access to innovative biologics.
Compensation / Benefits- Relocation benefits available
- Discretionary annual bonus
- Comprehensive benefits package
Responsibilities- Serve as analytical expert in a multi-disciplinary CMC team for clinical therapeutics (phase 1-3)
- Design and execute analytical studies supporting process development
- Enable regulatory filings (IND, BLA) through robust analytical data and methods
- Apply diverse analytical techniques (HPLC, LC-MS, CE, spectroscopy)
- Contribute to protein/biologics characterization and quality control
- Present data at internal and external meetings and collaborate with cross-functional teams
- Drive tasks to completion in a dynamic, fast-paced environment
Key requirements- Ph.D. with 4-6 years experience or Master's/Bachelor's with 6-10 years experience in Analytical Chemistry, Biology, Biochemistry, Chemistry, or Chemical Engineering
- Fundamental knowledge in analytical characterization of proteins or related modalities
- Hands-on experience with HPLC, LC-MS, capillary electrophoresis, and advanced spectroscopy (at least one deep area)
- Knowledge of CMC development from Phase I to commercial
- Strong communication and organizational skills; ability to work independently and in a team; data presentation experience
- Self-motivated
- excellent organization
- oral and written communication
- Analytical chemistry fundamentals
- HPLC
- LC-MS
