Industry leading cell and gene therapy company is hiring for TWO experienced QC Scientists. Located in the Bay Area, an industry hub, this opportunity is a great next step in your career and someone in your network.
About the role:
- Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle across clients.
- Support routine GMP testing as assigned.
- Evaluate corporate and regulatory requirements along with coordination of activities for implementation of these requirements.
- Writing of Analytical Method Transfer and Validation life cycle documentation i.e. master plans, protocols, test methods, and reports.
- Create validation project plan
- Perform troubleshooting activities with respect to methods/assays, equipment malfunctions and investigations (Deviations and OOS).
- Train QC personnel during method transfer and validation.
- Set deadlines and prioritize work for self, group members, and support groups involved, as well as review/approve work performed by coworkers.
- Deliver technical presentations internally and externally to clients and at conferences.
Desired Qualifications:
Bachelor's degree in Life Sciences or equivalent, advanced scientific degree desirable.
8-10 years relevant experience in Quality Control or MS/Ph.D. in Analytical Biological or other scientific field with demonstrated experience in Quality Control laboratories for biotechnology products.
Strong background and in-depth knowledge in analytical biological assays e.g. Flow Cytometry, ELISA, CE, PCR, Cell culture, platting, Mycoplasma, cell based assays, BD, Miltenyi related equipment for flow cytometry, 8 color staining etc.
- Extensive knowledge and experience of QC assay development, transfer and validation, along with cGMPs.
- Strong background and in-depth knowledge in analytical chemistry e.g. Flow Cytometry, ELISA, HPLC, CE, PCR, etc.
If this is an opportunity that you or someone in your network would be interested in, apply in!
