Overview
Senior Underwriter, Life Sciences Jobs in Chino, California, USA at Everest Insurance
Position: SENIOR UNDERWRITER, LIFE SCIENCES
A pharmaceutical company in California is currently seeking a new Senior Manager, CMC QC to join their growing team in San Mateo Country. In this role, the Senior Manager, CMC QC will be responsible for all CMC QC Program support for the biological programs.
Responsibilities :
Support the development, validation, and transfer of analytical methods used for QC testing of biologics
Manage, review, and organize Release / stability, method validation / transfer data from active stability programs and generate interim stability trending assessments and reports
Support the external contract organization activities to fulfill the GMP QC testing for release / stability and method validation / transfer needs
Provide internal support to QC operations to support the development, manufacture, method validation / transfer and release / stability activities, of Biologics
Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies
Implement and maintain quality systems to ensure the integrity and reliability of QC data
Participate in stability programs for clinical and commercial products in accordance with ICH / FDA / EMA / USP / Ph. Eur. guidelines
Perform other duties, as needed
Qualifications :
3+ years of experience with Analytical and QC experience in a GMP environment (Biotech and / or Pharma)
Bachelors Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
Experience with a good understanding of biologics drug substance processes; encompassing the initial cell culture and production phases (upstream), as well as the subsequent purification and isolation steps to create the final drug substance (downstream)
Solid analytical and problem solving skills
Great interpersonal skills
Excellent communication skills (written and verbal)
Strong attention to detail
Highly organized
Desired Skills :
Working experience and knowledge in a wide variety of Quality Control Stability methodologies
Experience in conducting Stability Studies per ICH Guidelines
Proficient in Statistical Analysis software (Excel / JMP)
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Title: Senior Underwriter, Life Sciences
Company: Everest Insurance
Location: Chino, California, USA
Category: Quality Assurance – QA/QC, Healthcare
