Job Category: Clinical: Scientific
Job Number: 2761
This position reports to the 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 independently in a collaborative, scientifically stimulating, patient-focused environment.
- The job responsibility may change as needed to support activities relevant to clinical phase.
- Independently motivated and detail-oriented, with excellent problem-solving abilities for interrogating complex molecular entities.
- BS/MS Analytical Chemistry, Biochemistry, Biophysics or a related discipline with at least 3-6 years of experience working in cGMP environment.
- Experience with DNA/RNA and/or protein purification, separation and analytical characterization is strongly preferred.
- HPLC/UPLC experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials by a variety of chromatographic methods (RP, SEC, IEX) is strongly preferred.
- Knowledge and hands-on experience with physicochemical characterization techniques, including but not limited to: LCMS, GCMS, AUC, CE-SDS, cIEF, MALS/DLS, DSC.
- Experience with statistical analysis software (SoftMax, JMP) preferred.
- Experience working with external contract labs (CMOs, CROs) is a plus.
- Experience executing late-stage analytical comparability studies is preferred.
- Ability and desire to work in a fast-paced, start-up environment.
- Strong collaboration and team-working skills.
- Strong communication, interpersonal and organizational skills.
- Proven ability to work independently and effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
- Should be highly motivated, demonstrate strong technical leadership skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
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