JRG Partners is exclusively representing a pioneering biopharmaceutical company at the forefront of developing next-generation therapeutics. We are seeking a visionary and highly accomplished Vice President of Bioprocess Development & Manufacturing to join their executive leadership team in the vibrant hub of Research Triangle, North Carolina. This is a career-defining opportunity to build and lead a world-class bioprocess function, shaping the technical and strategic direction for the company’s innovative pipeline from early-stage development through to commercialization.

As the VP, you will hold ultimate responsibility for all aspects of process development, scale-up, technology transfer, and clinical/commercial manufacturing for our client’s portfolio of complex biologics. You will be instrumental in designing and executing a robust CMC (Chemistry, Manufacturing, and Controls) strategy that is scientifically sound, phase-appropriate, and compliant with global regulatory standards. This role requires a unique blend of deep scientific expertise, strategic thinking, operational excellence, and inspirational leadership. You will be the primary architect of the infrastructure, teams, and processes necessary to translate groundbreaking research into life-changing medicines for patients worldwide. Your leadership will directly impact the company’s ability to meet critical clinical milestones and achieve long-term commercial success. You will foster a culture of innovation, collaboration, and continuous improvement, ensuring the organization remains on the cutting edge of bioprocessing technology and manufacturing sciences.

Key Responsibilities of VP Bioprocess Development & Manufacturing – Research Triangle, NC

The successful candidate will be a hands-on leader, capable of managing both strategic initiatives and tactical execution. Your responsibilities will be broad and impactful, encompassing the entire product lifecycle.

Strategic & Technical Leadership:

Develop and execute a comprehensive, long-range strategic plan for the Bioprocess Development and Manufacturing department, aligning with overall corporate goals and product development timelines.

Provide expert scientific and technical leadership in all areas of bioprocessing, including cell line development, upstream process development (cell culture), downstream process development (purification), and formulation development.

Oversee the design and execution of experiments for process characterization, optimization, and validation to establish a robust and scalable manufacturing process.

Drive the evaluation and implementation of new and innovative technologies, automation, and methodologies to enhance process efficiency, product quality, and cost-effectiveness.

Manufacturing & Supply Chain Oversight:

Lead all manufacturing operations, including the strategic selection, qualification, and management of Contract Development and Manufacturing Organizations (CDMOs).

Direct the successful technology transfer of manufacturing processes to internal or external cGMP manufacturing sites, ensuring seamless execution and process performance.

Ensure the reliable and compliant supply of drug substance and drug product for all preclinical, clinical, and future commercial needs.

Establish and monitor key performance indicators (KPIs) for manufacturing operations, focusing on quality, yield, timeline adherence, and budget control.

Regulatory & Quality Compliance:

Ensure all process development and manufacturing activities are conducted in strict accordance with Current Good Manufacturing Practices (cGMP) , ICH guidelines, and other global regulatory requirements.

Lead the authoring and review of all CMC-related sections for regulatory submissions, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), and responses to regulatory agency inquiries.

Serve as the primary subject matter expert during regulatory inspections and interactions with health authorities such as the FDA and EMA.

Collaborate closely with the Quality Assurance department to build a strong quality culture, resolve deviations, implement CAPAs, and ensure robust quality systems are in place.

Team & Financial Management:

Recruit, develop, and mentor a high-performing team of scientists, engineers, and manufacturing professionals. Foster a collaborative, inclusive, and results-oriented environment.

Establish departmental goals and objectives, provide regular performance feedback, and support the professional growth of team members.

Develop and manage the annual departmental budget, ensuring prudent allocation of resources to meet strategic objectives.

Effectively manage cross-functional relationships with Research, Clinical Operations, Regulatory Affairs, and Project Management to ensure seamless program execution.

Requirements for the VP Bioprocess Development & Manufacturing – Research Triangle, NC

We are seeking a seasoned leader with a proven track record of success in the biopharmaceutical industry. The ideal candidate will possess the following qualifications:

Education

A Ph.D. in Chemical Engineering, Biochemical Engineering, Biochemistry, Biology, or a closely related scientific discipline is strongly preferred. An M.S. with extensive, directly relevant experience will be considered.

Experience

A minimum of 15 years of progressive experience in the biotechnology or pharmaceutical industry, with at least 8 years in a senior leadership role overseeing bioprocess development and/or cGMP manufacturing functions.

Technical Expertise

Deep, hands-on experience with the development and manufacturing of biologics (e.g., monoclonal antibodies, recombinant proteins, cell/gene therapies). Demonstrated expertise across the full spectrum of bioprocessing, including upstream, downstream, and analytical development.

Regulatory Acumen

Extensive experience with CMC regulatory requirements and a proven track record of successful IND and BLA/MAA submissions. Direct experience interacting with regulatory agencies is essential.

CDMO Management

Significant experience in selecting, managing, and overseeing CDMOs for process development, technology transfer, and cGMP manufacturing is required.

Leadership Skills

Exceptional leadership, communication, and interpersonal skills. Proven ability to build and lead high-performing teams, influence stakeholders across the organization, and make sound strategic decisions in a fast-paced environment.

Strategic Mindset

Ability to think strategically and translate corporate objectives into actionable departmental plans. Experience with late-stage clinical development, process validation, and commercial launch preparation is highly desirable.

Location

Must be willing to work on-site in the Research Triangle, NC area.

Benefits & Perks Offered

Our client is committed to attracting and retaining top talent by offering a highly competitive compensation and benefits package, including:

Competitive Compensation

A generous base salary, annual performance-based bonus, and a significant equity package (stock options/RSUs).

Comprehensive Health Coverage

Premium medical, dental, and vision insurance for you and your eligible dependents.

Retirement Savings

A 401(k) plan with a strong company match to help you plan for your future.

Work-Life Balance

A generous paid time off (PTO) policy, including vacation, sick leave, and paid holidays.

Professional Growth

A commitment to your professional development with opportunities for continued learning, conference attendance, and career advancement.

Relocation Assistance

A comprehensive relocation package is available for qualified candidates.

Innovative Culture

The opportunity to work in a dynamic, collaborative, and science-driven environment where your contributions have a direct impact on patient lives.

How to Apply

This is a retained search managed exclusively by JRG Partners. If you are a transformative leader with the experience and passion to build a world-class biomanufacturing function, we invite you to apply. Please submit your resume and a cover letter detailing your qualifications and interest in the role.

JRG Partners is a leader in connecting exceptional talent with groundbreaking companies in the life sciences sector. To learn more about our expertise and explore other opportunities, please visit our page on Top Biosciences Executive Recruiters practice . We look forward to reviewing your application.