QC Virology Scientist Direct Hire MA

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Job ID: 16057 Direct Hire MA

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Our growing Gene Therapy client is looking to bring on board a Scientist to their growing Quality Control Virology team!  This role will review and trend development, GMP and stability data, generating reports as necessary, support the development and implementation of GMP quality systems and assist with authoring appropriate SOPs and implementing training programs to support QC and related GXP processes.  Sr. RA/Scientist will support the gene therapy program pipeline including but not limited to technical transfer, method qualification and/or validation and routine GMP testing of AAV vector and AdV analytical methods (TCID50, rcAAV, residual infectious Ad, and other methods as needed), support viral clearance studies and external laboratory testing and internal study protocol design, study report review and IND support as needed.  Will support successful technical transfer, method qualification, troubleshooting and routine GMP testing for cell based infectivity, and virus detection assays. Engaging with in-house teams and external QC test labs and CMOs, oversee and manage: QC data review, method validation activities, protocol review and report finalization.

Responsibilities:

  • Support the development, technical transfer and validation of cell based viral assays.
  • Perform cell based viral assays to generate characterization, release and stability data
  • Work independently to review and trend QC data, generating stability and other trending reports as necessary
  • Prepare, analyze and trend QC data
  • Prepare stability reports
  • Support the development of QC systems and SOPs, to enable in-house QC release testing.
  • Support QC deviations, investigations, analytical method performance trending and root cause analysis.
  • Work with cross functional teams

Requirements:

  • BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 4+ years industry experience
  • Experience with viral propagation and cell based infectious assays required, and experience with routine cell culture strongly desired
  • Experience developing and qualifying biological methods in one of the following areas: immunoassays, cell-based assays, and microbiological assays 
  • Experience drafting protocols, data reports and QC/QA compliance documents
  • Experience with statistical analysis of analytical data and stability studies preferred
  • Experience with viral vectors is not required but experience with biologics preferred
  • Familiarity with PCR, in particular qPCR and/or ddPCR
  • Ability and desire to work in a fast-paced, start-up environment