Clinical-stage Biopharma/Gene Therapy company focusing on rare and serious diseases
Greater Boston, MA area
Sr. Research Associate, Analytical Testing & QC
Full time, permanent
- Execute GMP release and stability GMP testing and R&D testing for API, bulk drug substance and final drug product intended for clinical supply and provides timely and accurate data generation using a variety of assays including HPLC techniques and plate-based methods.
- Maintain and analyze method performance trending and provide documentation
- Collaborate with Analytical Development group to implement accurate, repeatable assays for a variety of nanoparticle components and novel nanoparticle formulations.
- Work cross-functionally to support R&D studies, manufacturing, regulatory filings and stability programs
- BS or MS in Chemistry or a related field with a minimum of 8 years of industry experience (min of 5 with a MS)
- Experience in HPLC separations including reversed-phase, normal phase and SEC with a variety of detection modes and plate-based assays including instrumentation troubleshooting is required; ELSD experience is a bonus
- Experience in writing GMP documents such as stability reports, analytical method qualification and validation protocols
If you meet the requirements above and would like to be considered for this position, apply on-line now for immediate consideration and to be contacted with further details