Protein Scientist - Analytical Lead (CA, CA)
Position Overview: We are seeking a senior anlaytical protein-scientist with 10-15 years of biotech industrial experience to lead the analytical development of our hemoglobin based oxygen carrier, from the non-clinical /cGMP stage to beyond. This is a full-time position, on-site in Thousand Oaks, CA, for a self-driven professional. Key responsibilities:
- Lead and execute the development of robust analytical methods for protein-based products.
- Identify and prioritize assays both in-house and outsourced; establish vendors and contracts as needed.
- Qualify starting, in-process and final release of materials.
- Validate assays and protocols to measure purity, potency, and stability to GMP standards, including ELISA, gel electrophoresis and chromatographic-based assays.
- Set up lab and storage including samples for control and long-term stability programs.
- Design, write and help document SOPs, analytical protocols, CoA and reports to GMP standards.
- Bachelor’s degree or above in biological sciences and/or chemistry
- 10-15 years industrial experience in analytical method development and qualification activities.
- Track record in analytical method development for protein biologics, both compendial and non-compendial, such as HPLC (SEC, AEX/CEX, HIC, RP, etc.) and additional product-specific methods such as ELISAs, electrophoretic methods (SDS-PAGE, icIEF), endotoxin, osmolality, pH, potency assays, PCR, Western Blot, LC-MS and other MS-based methods.
- Experience in transitioning to GMP , including SOP development, methods validation, and phase appropriate quality systems, including deviations, CAPA, change control, and document management systems.
- Strong problem Solving Skills (identify issues and root causes), communication skills (explain complex concepts and issues succinctly), interpersonal skills (seek buy-in and collaboration), and attention to details are essential in this role.
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