Lead Analyst, Quality Control
Avid Bioservices•Tustin, CA
•$46 - $58•Onsite
About The Position
Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. The Lead Analyst, Quality Control will lead and perform testing and sampling to support manufacturing, validation, process development and stability studies in a GMP environment.
Requirements
- Bachelor’s degree in biology, biochemistry, chemistry, or equivalent scientific field.
- Minimum 6 years of relevant hands-on experience working in a GMP environment.
- Experience with analytical testing and equipment, writing reports/procedures/specifications, GMPs and regulatory audits.
- Strong Cell-Based Assay, qPCR, ELISA, Analytical Biochemistry and/or Chemistry experience.
Nice To Haves
- Experience with cell-based assays, qPCR, electrophoresis, chromatography, aseptic techniques, and assay validation/qualification.
Responsibilities
- Lead and coordinate filled visual inspection for product lot release.
- Lead and execute assay qualification, method validation, special studies, investigations, method development and tech transfer projects.
- Work independently and navigate testing and analytical instrumentation with minimum instruction.
- Act as Subject Matter Expert for multiple testing methodologies and instruments.
- Perform and review routine cell maintenance, cell-based assays, ELISA, electrophoresis (SDS-PAGE), immunoblot, and qPCR testing of drug substance and drug products with strict adherence to written analytical test procedures.
- Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry.
- Provide guidance to Jr. Analysts and Analysts regarding lab work.
- Review, revise, and write test methods, standard operating procedures and may perform trending analysis.
- Write study protocols and reports; train other analysts; collaborate with other departments in developing, revising, and implementing QC procedures and policies.
- Stay abreast of company cGMPs and applicable industry regulations.
- Participate in regulatory inspections.
- Actively participate in departmental continuous improvement efforts.
- Perform other duties as assigned.
Benefits
- health, dental, and vision insurance
- 401(k) matching
- paid time off
- performance-based bonuses
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What This Job Offers
Job Type
Full-time
Career Level
Senior
