Vice President of CMC (Chemistry, Manufacturing, & Controls)
Location: San Diego, California
Employment Type: Full-time
Compensation: $250,000 - $300,000
About The Client
Our client is a forward-thinking biopharmaceutical company dedicated to transforming innovative science into real-world therapeutic solutions. The team is united by a shared purpose: to bring life-changing treatments to patients through cutting-edge research, rigorous development standards, and operational excellence. They believe in cultivating a culture of transparency, integrity, and relentless curiosity-where collaboration is key, and every team member plays an essential role in the bigger mission.
They are seeking leaders who are not only scientifically driven but also thrive in a dynamic environment that values both independence and teamwork. If you're motivated by impact and inspired by the challenge of building things the right way from the ground up, we'd love to connect.
About the Role
We're hiring a Vice President of Chemistry, Manufacturing, and Controls (CMC) to lead our large molecule development programs and serve as the company's internal subject matter expert across all CMC functions. This individual will be responsible for driving technical strategy, managing outsourced manufacturing partnerships, and overseeing all aspects of CMC development-from early-stage development through commercialization.
This is a high-impact leadership role that requires a blend of scientific expertise, operational savvy, and strategic foresight. The ideal candidate brings deep experience in biologics or large molecule therapeutics, excels at cross-functional collaboration, and thrives in a growth-stage biotech environment.
Key Responsibilities
Strategic Leadership
- Own the end-to-end CMC strategy across all programs in development.
- Translate development goals into robust CMC plans, ensuring alignment across R&D, Clinical, Quality, and Regulatory functions.
- Develop long-term commercial manufacturing strategies that consider demand forecasting, investment planning, inventory control, and vendor relationships.
- Proactively identify and mitigate supply chain and technical risks.
Operational Oversight
- Oversee all outsourced manufacturing activities, including CDMO selection, contract negotiation, and performance management.
- Ensure timely delivery of clinical and commercial supply, maintaining quality and compliance throughout.
- Lead the development of budgets and timelines for CMC operations and report regularly to executive leadership.
- Drive cross-functional meetings and milestone planning to support timely execution across programs.
Manufacturing & Technical Execution
- Supervise drug substance and drug product manufacturing, labeling, packaging, and distribution.
- Oversee sourcing and logistics for raw materials, APIs, and equipment.
- Manage analytical method development and validation, as well as QC review and approval.
- Participate in manufacturing site visits and vendor audits.
Regulatory Affairs
- Collaborate with Regulatory Affairs to support the preparation and submission of CMC sections for INDs, CTAs, and BLAs.
- Address CMC-related questions from regulatory authorities and ensure submission timelines are met.
Qualifications
- PhD in Organic Chemistry, Pharmaceutics, Chemical Engineering, or related scientific discipline.
- Minimum 15 years of pharmaceutical industry experience, with a strong track record in CMC leadership and biologics development.
- Extensive experience working with CDMOs and managing external partnerships.
- In-depth knowledge of cGMP regulations and best practices in both clinical and commercial manufacturing.
- Demonstrated success in process development, scale-up, and validation.
- Prior experience drafting and submitting CMC content for regulatory filings in the U.S. and international markets.
- Strong communication, project management, and organizational skills.
- Proven ability to lead cross-functional teams in a fast-paced, evolving environment.
Additional Information
- Must be authorized to work in the United States.
- Salary will be commensurate with experience and qualifications.
- Comprehensive health and wellness benefits are available to eligible employees.
- We are an equal opportunity employer and are committed to fostering an inclusive and diverse workplace. All applicants are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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