Kelly Services
Location
San Diego, CA | United States
Job description
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
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
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