Senior Analyst | Scientist, Quality Control Chemistry

Location: Woburn, MA

Length: 6-month contract

Pay Rate: $42-52/hr.

Position Summary

The Senior Analyst / Scientist’s primary responsibility will be maintaining and troubleshooting LC-MS instruments and leading/supporting method lifecycle activities for LC-MS test method in support of routine GMP release and stability testing.

The Senior Analyst / Scientist will also support the gene therapy program pipeline including but not limited to technical transfer, method qualification, validation, verification, routine GMP testing of AAV vector analytical methods (HPLC, AUC, UV, CE-SDS, compendia methods and other methods as needed) for lot release and stability.

The Senior Analyst/ Scientist, Quality Control Chemistry, will support external laboratory testing and internal study protocol design, study report review and IND support as needed.

The Senior Analyst / Scientist will work cross-functionally with others in Quality Control, Analytical Development teams, Quality Assurance, and Manufacturing, as needed. The individual will also work on data trending, invalid assays investigations, quality events (investigations, deviations, Change control, CAPAs) and analytical assays for AAV efficacy (potency), safety and product quality.

Responsibilities

• Execute analytical test methods to support the clinical development of new AAV pipeline candidates and release testing of commercial products.
• Work with CROs for method development, validation, verification, and transfer, as needed.
• Verify and pre-validate analytical test methods in preparation for method transfer to GMP CMO facilities, as needed.
• Lead and supports routine laboratory operations (equipment cleaning, laboratory cleaning, inventory control, logbook management)
• Ensures laboratory operational readiness and assists with troubleshooting/continuous improvement as needed.
• Support instrument lifecycle including, but not limited to, instrument on-boarding, validation and troubleshooting/maintenance.
• Write, prepare, and present technical data, technical reports, and standard operating procedures (SOPs) for internal use and transfer to external sites.
• Performs peer review of both internal and externally generated data.
• Lead and support QC deviations, investigations, CAPA, change control, analytical method performance trending and root cause analysis, as needed.
• Investigate and evaluate cutting edge biophysical and analytical instrumentation and stay up to date on state-of-the-art methodologies for AAV characterization.
• The job responsibilities may change as needed to support activities relevant to the clinical or commercial phase.

Qualifications:

• BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with at least 4 years of hands-on experience working with LC-MS based assays is in R&D / GLP/ cGMP environment is must.
• Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is 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 preferred.
• Experience working with external contract labs (CMOs, CROs) is a plus.
• Experience executing late-stage analytical comparability studies is preferred.
• 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.