Role Overview for VP CMC & Biomanufacturing – Research Triangle, NC
JRG Partners is proud to represent a pioneering, clinical-stage biotechnology company at the forefront of developing transformative therapies for patients with critical unmet medical needs. Situated in the vibrant hub of innovation, Research Triangle, NC, our client is driven by a passion for science and a commitment to excellence. We are seeking a visionary and highly strategic Vice President of Chemistry, Manufacturing, and Controls (CMC) & Biomanufacturing to join their executive leadership team. This is a career-defining opportunity to build and lead the entire CMC and manufacturing function from the ground up, shaping the technical and strategic direction that will carry novel biologic therapies from clinical development through to commercialization.
Reporting directly to the Chief Executive Officer, the VP of CMC & Biomanufacturing will be the single point of accountability for all aspects of drug substance and drug product development, manufacturing, quality control, and supply chain management. The ideal candidate is a seasoned leader with a profound understanding of the biopharmaceutical landscape, possessing a track record of successfully guiding complex biologic programs through all phases of development and regulatory approval. You will be responsible for creating a robust, scalable, and cGMP-compliant manufacturing strategy that aligns with the company’s ambitious clinical and commercial goals. This role requires a unique blend of deep scientific expertise, strategic business acumen, and inspirational leadership. You will be instrumental in building a world-class internal team while also managing a global network of contract development and manufacturing organizations (CDMOs). Your leadership will directly impact the company’s ability to deliver life-changing medicines to patients worldwide, making this a role of immense significance and visibility.
This position is based in the dynamic Research Triangle Park (RTP) area of North Carolina, a world-renowned center for life sciences research and development. The successful candidate will be expected to be a significant presence on-site, fostering a culture of collaboration, innovation, and urgency. You will serve as the company’s primary expert on all CMC-related matters, interacting with the Board of Directors, investors, and regulatory authorities. If you are a strategic thinker and an operational expert ready to make a tangible impact in a fast-paced, science-driven environment, we invite you to explore this exceptional opportunity.
Key Responsibilities of VP CMC & Biomanufacturing – Research Triangle, NC
Strategic Leadership & Vision
Develop and execute a comprehensive, phase-appropriate CMC and manufacturing strategy for the company’s portfolio of biologic candidates. This includes long-range planning for clinical and commercial supply, capacity planning, and technology platform development.
Process & Product Development
Provide scientific and technical leadership for all drug substance (DS) and drug product (DP) development activities, including cell line development, upstream and downstream process development, formulation development, and analytical method development and validation.
Manufacturing & Supply Chain Oversight
Lead all manufacturing operations, including the selection, negotiation, and management of a global network of CDMOs and suppliers. Oversee technology transfer, process scale-up, and process validation activities to ensure a reliable and compliant supply chain.
Regulatory Strategy & Submissions
Direct the preparation and review of all CMC-related sections for global regulatory submissions, including INDs, BLAs, and MAAs. Serve as the primary CMC expert during interactions with the FDA, EMA, and other health authorities.
Quality & Compliance Leadership
In close collaboration with the Quality Assurance function, ensure that all internal and external manufacturing activities are conducted in strict adherence to current Good Manufacturing Practices (cGMP), ICH guidelines, and other applicable global regulations. Implement robust quality control and stability programs.
Team Building & Mentorship
Recruit, develop, and lead a high-performing team of scientists, engineers, and manufacturing professionals. Foster a culture of scientific excellence, accountability, cross-functional collaboration, and continuous improvement.
Fiscal & Resource Management
Develop and manage departmental budgets, forecasts, and long-range financial plans. Ensure optimal allocation of resources to meet program timelines and corporate objectives.
Cross-Functional Collaboration
Serve as a key member of the executive leadership team, working closely with Research, Clinical Development, Regulatory Affairs, and Commercial functions to ensure seamless program integration and execution. Provide CMC expertise and input into overall corporate strategy.
Risk Management
Proactively identify and mitigate technical, regulatory, and supply chain risks associated with the company’s development programs. Develop contingency plans to ensure business continuity.
Technology & Innovation
Stay abreast of the latest advancements in bioprocessing technology, analytical science, and regulatory trends to ensure the company remains at the cutting edge of biomanufacturing.
Requirements for the VP CMC & Biomanufacturing – Research Triangle, NC
Educational Background
A Ph.D. in a relevant scientific or engineering discipline (e.g., Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field) is strongly preferred. An M.S. with extensive, directly relevant experience will be considered.
Professional Experience
A minimum of 15 years of progressive experience in the biopharmaceutical industry, with at least 10 years in a leadership capacity overseeing CMC development and manufacturing functions.
Technical Expertise
Demonstrated, in-depth knowledge of the entire biomanufacturing lifecycle for biologics (e.g., monoclonal antibodies, recombinant proteins, cell/gene therapies). Expertise must span process development (upstream and downstream), formulation, analytical development, technology transfer, and cGMP manufacturing.
Regulatory Acumen
Extensive, hands-on experience authoring and reviewing CMC sections of late-stage clinical and commercial regulatory filings (INDs, CTAs, BLAs, MAAs). Proven success in interacting with and presenting to global regulatory agencies is essential.
Leadership & Management Skills
A proven track record of building, leading, and mentoring high-performing technical teams. Must possess exceptional strategic thinking, problem-solving, and decision-making abilities. Experience managing multi-million dollar budgets is required.
CDMO Management
Significant experience in identifying, evaluating, and managing contract development and manufacturing organizations (CDMOs) for clinical and commercial supply. Strong negotiation and relationship management skills are critical.
Communication Skills
Outstanding written and verbal communication skills. The ability to articulate complex scientific and technical concepts clearly to diverse audiences, including executive leadership, board members, investors, and regulatory bodies.
Location
Must be willing to be based in or relocate to the Research Triangle, NC area to provide on-site leadership.
Personal Attributes
A results-oriented, agile, and collaborative leader with high emotional intelligence. Must be comfortable operating in a fast-paced, dynamic, and resource-constrained biotech environment. A strong sense of urgency and a commitment to patient outcomes are paramount.
Benefits & Perks Offered
Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package. This includes:
- A competitive base salary and annual performance-based bonus.
- A significant equity stake in the company, including stock options, providing a meaningful opportunity for ownership and long-term wealth creation.
- Comprehensive health, dental, and vision insurance for you and your eligible dependents.
- A robust 401(k) retirement savings plan with a generous company match.
- Generous paid time off (PTO), including vacation, sick leave, and company holidays.
- Relocation assistance for qualified candidates moving to the Research Triangle area.
- A professional development budget to support continuous learning, conference attendance, and career growth.
- The opportunity to work in a state-of-the-art facility alongside a team of brilliant and dedicated professionals.
- A dynamic, inclusive, and science-driven company culture where your contributions have a direct and visible impact on the future of the company and the lives of patients.
How to Apply
This is a retained search being conducted exclusively by JRG Partners. To be considered for this pivotal leadership role, please submit your resume and a cover letter detailing your qualifications and interest. JRG Partners is a leader in connecting exceptional talent with transformative opportunities in the biotechnology and pharmaceutical sectors. We encourage you to learn more about our specialized recruitment services by visiting our Best Biotech Recruiters practice area page. We look forward to reviewing your application and discussing how your expertise can drive the success of our innovative client.
