A biotechnology research organization located in Brisbane, CA is seeking a highly motivated and experienced professional as Manager/Senior Manager for the Clinical and Commercial Programs in the CMC Quality Control Department, with the passion and creativity to support development of great medicines. The Manager/Senior Manager will be responsible for all CMC QC Program support for the biological programs. The Manager/Senior Manager also will provide support to internal QC representatives who work with contract manufacturing organizations (CMOs) and Contract Laboratories (CLs) to ensure that appropriate quality and industrial standards are met to support of the quality control activities as assigned.
- Location: Brisbane, CA
- Assignment Length: Ongoing temporary engagement
- Work Schedule: Hybrid, 2 days onsite, 3 days work from home
- Hours: Full Time
Responsibilities including, but not limited to:
Main focus: The Manager/Senior Manager of CMC QC will work across the biological products/programs as assigned (Clinical & Commercial products at West Coast US) for quality control operational support:
- Method Development, Validation, and transfer: Support the development, validation, and transfer of analytical methods used for QC testing of biologics, small molecule and oligonucleotide products.
- QC data review: Manage, review, and organize Release/stability, method validation/transfer data from active stability programs and generate interim stability trending assessments and reports
- External Contract Organization management: Support the external contract organization activities to fulfill the GMP QC testing for release/stability and method validation/transfer needs.
- Quality Control Operational support: Provide internal support to QC operations to support the development, manufacture, method validation/transfer and release/stability activities, of Biologics.
- Regulatory Compliance: Ensure that all QC activities comply with regulatory requirements, including those of the FDA, EMA, and other relevant agencies.
- Quality Systems: Implement and maintain quality systems to ensure the integrity and reliability of QC data.
- Stability Program management: Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. guidelines
Requirements:
- Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
- Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
- Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
- 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).
- Working experience and knowledge in a wide variety of quality control stability methodologies is highly desirable
- Experience in conducting stability studies per ICH Guidelines is highly desirable.
- Good oral and written communication skills and a fast learner
- Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
- Proficiency in MS Office, Word and Excel
- Proficient in statistical analysis software desired (Excel/JMP)
