Senior Director, QC & Analytical Excellence
Bionova Scientific
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Benefits offered by this job
Job summary
Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead all QC operations and set strategy for release, stability, in-process and environmental monitoring programs.
You will guide analytical transfer, qualification, and validation, collaborating with clients and the Analytical Development team to meet timelines. This senior leadership role requires 15+ years in Analytical Sciences or GMP environments, with direct regulatory agency experience and a strong
Qualifications
- Advanced degree in Pharmaceutics, Biochemistry, Chemistry, Biochemical Engineering, or related discipline.
- 15+ years in Analytical Sciences/QC or GMP lab leadership.
- Strong understanding of biopharmaceutical development from cell line to market authorization.
- Experience with interactions with global regulatory agencies.
- Expertise in method optimization, transfer, qualification, and validation for release and stability.
- Deep knowledge of cGMP and data integrity.
Responsibilities
- Provide strategic and tactical leadership for QC laboratories and related operations.
- Apply deep technical expertise to support development, clinical, and commercial testing; troubleshoot and investigate.
- Ensure phase-appropriate compliance with global cGMP for release, stability, and environmental monitoring.
Skills
Education
Job description
Bionova Scientific LLC in Fremont, CA is seeking a Sr. Director of Quality Control to lead all QC operations and set strategy for release, stability, in-process and environmental monitoring programs.
You will guide analytical transfer, qualification, and validation, collaborating with clients and the Analytical Development team to meet timelines. This senior leadership role requires 15+ years in Analytical Sciences or GMP environments, with direct regulatory agency experience and a strong
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