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QC Analyst

Cambridge, MA 02139

Posted: 05/13/2022 Employment Type: Contract Job Category: Clinical: Quality Job Number: 3035

Job Description


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) and analytical assays for AAV efficacy (potency), safety and product quality.

Senior Analyst will specifically 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, LCMS, AUC, MALS/DLS, UV, SDS-PAGE, 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.

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
  • 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.
  • Perform routine activities for support QC lab operations.
  • 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 responsibilities may change as needed to support activities relevant to the clinical phase.

Qualifications:
  • Experience working in the cGMP QC lab of the pharmaceutical or biopharmaceutical industry is a must.
  • We are looking for an independently motivated and detail-oriented individual with excellent problem-solving abilities for interrogating complex molecular entities.
  • BS/MS Analytical Chemistry, Biochemistry, Biophysics, or a related discipline with 1 to 4 years of experience working in a cGMP environment.
  • Experience with DNA/RNA and/or protein purification, separation, and analytical characterization 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.
  • Knowledge and hands-on experience with physicochemical characterization techniques, including but not limited to LCMS, GCMS, AUC, CE-SDS, cIEF, MALS/DLS, DSC is preferred
  • 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 good technical skills, have excellent organizational and communication skills, and be able to multitask in a fast-paced environment with changing priorities.
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