Title: QC Scientist I/II
Location: San Diego, CA
Job Type: Full-Time, Temporary Contract
Shift: M-F, 1^st Shift, M-F
Salary: $84K-$118K (DOE) + Comprehensive Benefits

Job Overview

Kelly’s client is seeking a Scientist I/II of QC with broad knowledge and expertise in cell-based potency assays, molecular biology assays, and chemical/biochemical assays as applied to AAV gene therapy products. The scientist will be involved in transfer of method from Analytical Development into QC. The scientist will author and execute phase appropriate qualification/validation protocols and reports of QC methods to support product release and characterization. The role will perform potency analysis on lot release and stability samples for clinical phase, AAV Gene Therapy products.

-This is not a position with supervision responsibilities.
-This role oversees vendors and/or contractors as needed.

Responsibilities

Representative responsibilities will include, but not necessarily be limited to, the following:

• Collaborate with research, analytical development and process development teams to develop, qualify/validate AAV gene therapy cell-based biological potency assays, protein chemistry assays, and molecular biology assays for process monitoring and drug product release, specifically SDS-PAGE, western blot, droplet digital PCR or qPCR, culture of primary mammalian cells, and cell?based potency assays.
  

•  Participate in developing timelines, protocols and reports for assay transfers, qualifications / validations.
  

•  Contribute to establishing material specifications for drug substance and drug products
  

•  Author and review QC analytical SOPs, protocols, and reports as needed
  

•  Ensure the timely execution of all routine QC testing, data review, and preparation of summary reports
  

•  May act as an analytical lab representative on a CMC team.
  

•  Perform quality management activities such as deviation, CAPA, change control, investigation of OOS, OOT and anomalous results within the company QMS according to established procedures.
  

•  Participate in establishing sample plans, managing in-process and release test samples
  

•  Participate in establishing stability plans, managing stability tests and reference standards
  

•  Maintain QC laboratory, track critical reagents and equipment logbooks, and ensure all the equipment is calibrated

•  Software Use Expectations:

  • Utilize the LIMS system to submit samples, enter data, and track samples.
    

  •  Utilize statistical analysis software to generate assay control charts and recommend assay acceptance criteria.
    

  •  Learn and become proficient in all laboratory instrument software to conduct testing.
    

Qualifications

• BS or equivalent in relevant discipline with a minimum of 4-7 years of relevant industry experience or Master’s degree in relevant discipline with a minimum of 3 years of relevant industry experience
  

•  Experiences in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing, with experience in a GMP QC release testing role
  

•  Experiences in optimizing methods with particular emphasis on cell-based potency assay, molecular biology assay, and protein chemistry assays
  

•  Significant experience in an FDA-regulated environment
  

•  Entrepreneurial spirit, with strong willingness to take on new challenges required to bring novel medicines to the clinic
  

•  Excellent organizational and communication skills
  

•  Experience with JMP statistical software a plus.

Travel Requirements

Up to 10% Domestic and/or International travel required for method transfer activities

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