South San Francisco Categories:
Associate Director - Quality Control KaloBios Pharmaceuticals
THIS JOB HAS EXPIRED
Reports to: Head of QualityThe Associate Director of Quality Control will oversee the QC function at KaloBios and will report to the Head of Quality. The position will be responsible for developing and maintaining a state-of-the-art quality control program related to the testing of clinical supplies, and eventually commercial products, within the context of a small, virtual biotechnology company environment. This position also oversees bioanalytics and companion diagnostics analytical testing.
Oversee analytical method transfer, validation, routine use and redevelopment of QC and bioanalytical assays
Manage outside vendors and contract laboratories performing QC and bioanalytical assays
Contribute to CMC regulatory submissions
Prepare QC release documentation for products under GMP guidelines
Perform oversight relating to companion diagnostics programs
Oversee reference standard and stability programs
Develop and manage budgetary requirements relating to Quality Control
Update all SOPs and processes and work to consolidate contract work to manage QC workload more efficiently and cost effectively
Work closely with the Manufacturing and Pharmaceutical Development group to ensure the successful validation and routine testing of KaloBios products
Job Requirements:
BS/MS/PhD in a chemical or biological science, with 7+ years Quality Control management experience in a biotechnology/pharmaceutical company
Experience managing a Quality Control program with strong scientific, regulatory, and compliance experience
Laboratory experience developing and validating analytical methods for protein or (preferably) antibodies
Strong working knowledge of analytical method development, transfer, routine testing and validation for biomolecules
Experience managing Quality Control functions performed by third-party vendors and contractors
Proficient working knowledge of international GMP
Positive track record in creative problem solving, attention to detail and successfully meeting or exceeding deadlines
Financial analytical skills and budget management experience
Must be able to integrate scientific and regulatory know-how, leadership skills, and quality experience to maximal effect in a small biopharmaceutical company
Ability to work successfully with multi-disciplinary project teams
Outstanding organizational, communication, negotiation and presentation skills
| Location: | South San Francisco, CA United States |
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THIS JOB HAS EXPIRED
KaloBios Pharmaceuticals
Investors: 5AM Ventures, Alloy Ventures, MPM Capital, Sofinnova VenturesAll Jobs: at KaloBios Pharmaceuticals
| Web Site: | www.kalobios.com |
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| Headquarters: | 3427 Hillview Avenue Palo Alto, CA 94304 United States |
| Industry: | Biotechnology |
