TEMP Scientist I - QC Chemistry
This position reports to the Associate Director, Quality Control and will work with others in Quality Control, Analytical Development teams and CROs to develop, validate and transfer late-stage biophysical and analytical assays for AAV efficacy (potency), safety and product quality.
Scientist I will specifically support the gene therapy program pipeline including but not limited to technical transfer, method development, qualification and/or validation and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, MALS/DLS, UV, SDS-PAGE, CE-SDS, compendia methods and other methods as needed) for lot release and stability. The Scientist I, Quality Control Chemistry will support external laboratory testing and internal study protocol design, study report review and IND support as needed.
- Provide leadership and subject matter expertise for method development, transfer and validation activities for late-stage assays for AAV efficacy (potency), safety and product quality.
- Devise, test, and develop new biophysical and analytical methods to measure and monitor key quality attributes for AAV therapeutic materials.
- Execute biophysical and analytical test methods to support the clinical development of new AAV pipeline candidates.
- Verify and pre-validate analytical test methods in preparation for method transfer to GMP CMO facilities.
- Investigate and evaluate cutting edge biophysical and analytical instrumentation, and stay up-to-date on state-of-the-art methodologies for AAV characterization.
- On-board new instruments to the lab.
- Write, prepare, and present technical data, technical reports and standard operating procedures (SOPs) for internal use and transfer to external sites.
- Work on laboratory investigation, change control, deviation and CAPA as appropriate for internal and external testing.
- Work independently in a collaborative, scientifically stimulating, patient-focused environment.
- The job responsibility may change as needed to support activities relevant to clinical phase.