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Head of CMC
681 Gateway Blvd South San Francisco, CA 94080 US
Job Description
The Individual will collaborate with QA, Regulatory, SMEs, and CMOs for CMC formulation development, method development, process development, storage/inventory management, logistics etc.
RESPONSIBILITIES:
- Manage CDMOs and review contracts, invoices, and payments
- Interface with QA, SMEs, and regulatory in the management of all aspects of CMC development
- Review or initiate CMC related documents
- Work closely with SMEs and CMOs to ensure all CMC deliverables and activities are aligned with corp. objectives
- Coordinate all CMC sub-team meetings, documenting meeting agenda and minutes, and managing action items
- Implement CMC strategy
- Identify potential risks and risk management strategies
- Collaborate with SMEs for election of new vendors, release batches, API, drug product
- Inventory management
- As needed, work closely with SMEs in the lab to resolve CMC product development formulation related issues
- PhD with 5-10 years’ experience in AAV CMC drug development function,
- Experience in early stage drug development and manufacturing
- Experience in CMO management
- Experience in risk identification and mitigation
- Ability to work independently (with minimal supervision) in a fast-paced team environment.
- Knowledge of cGMP requirements for pharma / biotech industry
- Biologics experience
- Regulatory environment
- Process, procedures and best practices
- Proficient in Microsoft Office (Word, Excel, and Power Point) and Smartsheet
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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