SENIOR INFORMATION SECURITY ANALYST Any Contract Intern

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)
• Bachelor’s 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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