Vice President of CMC
Benefits
5w PTO
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Accountabilities:
- Own CMC strategy and execution across the full portfolio, including drug substance, drug product, analytics, stability, supply, GMP responsibilities, and regulatory submission content.
- Lead selection, contracting, and ongoing management of CDMOs, testing laboratories, suppliers, consultants, and technical experts.
- Provide CMC leadership for regulatory submissions, including authoring and overseeing Module 3 content for IND filings.
Requirements:
- 10+ years of experience in CMC, pharmaceutical development, or related technical functions, including significant ownership of CMC activities for development programs.
- Proven experience managing external manufacturing partners, including CDMOs, through clinical development, technology transfer, scale-up, and clinical supply activities.
- Demonstrated ability to lead CMC sections of regulatory submissions, including IND submissions and ideally contributions to NDA, BLA, or major regulatory amendments.
Benefits:
- Competitive compensation package with meaningful equity opportunities.
- Fully remote work environment for candidates based in the United States or United Kingdom.
- 27 days of annual leave plus 11 national holidays, monthly wellness allowance, and enhanced parental leave benefits.
Partner Company
The company is a partner organization in the biopharmaceutical industry, focusing on clinical-stage therapeutic programs. It operates in a high-growth, mission-driven environment with a culture of innovation and collaboration.