Senior Analyst I, Quality Control Chemistry

The Senior Analyst will specifically support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, assay trending and routine GMP testing of AAV vector analytical methods (HPLC, LCMS, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability. Senior Analyst, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.

This position will work with others in Quality Control, Analytical Development teams, Quality Assurance, Manufacturing and CROs to perform routine QC testing of in-process, DS, DP, and raw material samples. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs).

• Responsibilities:Execute analytical test methods to support product release and stability of AAV products using different analytical techniques (e.g. HPLC, LCMS, AUC, UV, CE-SDS, compendia methods like Osmolality, pH, Sub visible particulates and Appearance)
• Review and approval of cGMP analytical data for release and stability testing from chemistry analytical test methods
• Supports and leads QC Chemistry laboratory operations (ex. Instrument qualification and maintenance. Housekeeping, qualify critical reagents, etc.).
• Author and support quality events; Change controls, Deviation, CAPA, OOS Investigation, as needed.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs), Method transfer/ validation protocol, Method transfer/ validation report for internal and external methods.
• Method Transfer / Validation of QC chemistry methods at internal and external laboratory.
• Model leadership behaviors and mentor/train junior staff
• The job responsibilities may change as needed to support activities relevant to the clinical phase.
• Requirements / Qualifications:BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 5 years of experience working in a cGMP environment.
• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
• Experience analyzing nucleic acids, virus capsids, antibodies, and/or other biologics materials using HPLC/UPLC, LCMS, AUC, UV- Vis, CE-SDS is strongly preferred.
• Experience working with external contract labs (CMOs, CROs) is a plus.
• 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 good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.