Oversee cGMP release and stability testing for drug products and drug substances to support clinical development programs, commercial products and regulatory submissions.
Manage method validation and transfer at Contract Testing Organizations (CTO) for drug products and drug substances. Write and review relevant regulatory documents to support regulatory filings (IND, NDA, etc.).
Essential Functions:
- Manage method validation activities at Contract Testing Organizations (CTO) for drug substances and drug products in various stages of clinical development
- Manage method transfer activities between contract testing labs and/or contract manufacturing organizations to support manufacturing and testing of drug products, drug substances and raw materials as required
- Manager release testing of drug substances, drug products and raw materials
- Develop and oversee stability programs for drug substance and drug products at contract testing labs, including ICH registration stability studies and commercial products stability programs
- Perform technical review of release and stability data, provide stability summaries and trends for regulatory submissions.
- Develop specifications for drug substances and drug products
- Maintain Reference Standards Program
- Support quality investigations related to release and stability testing.
- Work closely with Quality Assurance and Regulatory groups to ensure compliance to cGMPs and regulatory filings and requirements.
- Develop QC documentation, processes and procedures to support growing infrastructure and train and monitor personnel in complying with those activities.
- Write and review regulatory documents to support regulatory filings (IND, NDA, etc.)
Education
B.A./B.S. degree in a scientific discipline or the equivalent education and experience.
Experience:
At least 10 (ten) years of experience in pharmaceutical drug development focusing on Analytical Development/QC. Experience in analytical testing of sterile products is preferred. Experience in analytical testing of biologics is highly desirable. Experience in conducting ICH registration stability studies, release and stability testing at CTOs is required. Hands on experience and a solid understanding of a variety of analytical methods, and regulatory guidelines related to testing of drug substances and drug products, method validation and transfers is required. Ability to communicate technical information and details clearly and effectively both verbally and in writing is required. Ability to exercise sound judgment, reasoning and problem solving with minimal guidance is essential. Experience in writing regulatory documents for regulatory submissions is highly desirable.
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