Protein Scientist - Analytical Lead (CA, CA)

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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.

Requirements Summary

Bachelor’s degree or above in biological sciences and/or chemistry 10-15 years industrial experience in analytical method development and qualification activities.

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OtherScientist

Job Title: Protein Scientist -Analytical Lead
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.

Requirements:

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.

This is an excellent opportunity for a motivated individual to grow and excel in a growing biopharma company and to help develop a groundbreaking drug that could have an impact on the life of many.

Visit Careers at CEDENT

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