Role Overview for VP of Manufacturing (Biologics) – Boston, MA
JRG Partners is actively seeking a highly accomplished and visionary Vice President of Manufacturing (Biologics) to lead and strategically elevate the manufacturing operations for a pioneering biotechnology firm in the vibrant Boston, MA area. This pivotal leadership role demands an individual with an exceptional blend of technical expertise in biologics manufacturing, a proven track record in cGMP environments, and profound strategic acumen to drive operational excellence, innovation, and scalability.
The successful candidate will be instrumental in shaping the future of biologics production, ensuring the highest standards of quality, compliance, and efficiency from clinical supply to commercialization. This is a unique opportunity to join a forward-thinking organization at the forefront of medical innovation, contributing directly to the delivery of life-changing therapies to patients worldwide.
As VP of Manufacturing, you will be responsible for overseeing all aspects of drug substance and drug product manufacturing, including upstream and downstream processing, sterile fill-finish operations, and supply chain integration. Your leadership will be critical in building and mentoring high-performing teams, fostering a culture of continuous improvement, and implementing cutting-edge manufacturing technologies.
This role requires a leader who can navigate complex regulatory landscapes, drive strategic initiatives, and collaborate cross-functionally with R&D, Quality Assurance, Regulatory Affairs, and Supply Chain to ensure seamless product development and commercialization. If you are a transformative leader with a passion for advancing biologics manufacturing and a desire to make a significant impact, we invite you to explore this exceptional opportunity with JRG Partners.
Key Responsibilities of VP of Manufacturing (Biologics) – Boston, MA
Strategic Leadership & Vision
Develop, articulate, and execute a comprehensive manufacturing strategy for biologics that aligns with the company’s overall business objectives, pipeline growth, and long-term vision. This includes capacity planning, technology roadmapping, and facility expansion strategies to support both clinical and commercial demands.
Operational Excellence
Oversee all manufacturing operations, ensuring efficient, cost-effective, and timely production of biologics drug substance and drug product. Drive continuous improvement initiatives using Lean, Six Sigma, and other methodologies to optimize processes, reduce waste, and enhance productivity while maintaining stringent quality standards.
cGMP Compliance & Quality Assurance
Ensure strict adherence to current Good Manufacturing Practices (cGMP), FDA regulations, EMA guidelines, and other relevant international regulatory requirements. Foster a robust quality culture throughout the manufacturing organization, collaborating closely with Quality Assurance to manage deviations, CAPAs, and change controls effectively. Adherence to current Good Manufacturing Practices (cGMP) is paramount, ensuring all processes meet or exceed the latest regulatory guidelines established by health authorities.
Team Leadership & Development
Recruit, mentor, and develop a high-performing manufacturing team, including directors, managers, and operational staff. Foster an environment of collaboration, accountability, continuous learning, and professional growth. Conduct performance reviews, set clear objectives, and promote a culture of safety and operational excellence.
Budget & Resource Management
Develop and manage the annual manufacturing budget, optimizing resource allocation, controlling operational costs, and identifying opportunities for cost efficiencies without compromising quality or compliance. Oversee capital expenditure projects related to manufacturing expansion or technology upgrades.
Technology & Innovation
Evaluate, recommend, and implement innovative manufacturing technologies, automation solutions, and process improvements to enhance efficiency, reduce risk, and improve product quality. Stay abreast of industry trends, emerging technologies, and best practices in biologics manufacturing.
Supply Chain & Logistics Integration
Collaborate closely with Supply Chain, Procurement, and Logistics teams to ensure a robust and resilient supply chain for raw materials, consumables, and finished products. Manage inventory levels, mitigate supply risks, and optimize logistics to support global distribution.
Regulatory Inspections & Audits
Serve as the primary manufacturing representative during regulatory inspections (e.g., FDA, EMA) and internal/external audits. Ensure all manufacturing documentation, processes, and facilities are inspection-ready and respond effectively to findings.
Cross-Functional Collaboration
Work seamlessly with R&D for tech transfer and process industrialization, with Regulatory Affairs for submission support, and with Commercial teams to meet market demands and launch new products successfully.
Risk Management
Identify potential risks in manufacturing operations and develop robust mitigation strategies to ensure business continuity and product supply.
Requirements for the VP of Manufacturing (Biologics) – Boston, MA
Education
A Ph.D. or Master’s degree in Biotechnology, Chemical Engineering, Biochemistry, or a related scientific or engineering discipline is highly preferred. A Bachelor’s degree with extensive relevant experience may be considered.
Experience
Minimum of 15+ years of progressive experience in biologics manufacturing within the pharmaceutical or biotechnology industry, with at least 7-10 years in a senior leadership role overseeing significant manufacturing operations. Experience with both drug substance and drug product manufacturing, including sterile fill-finish, is essential.
Technical Expertise
Deep understanding and hands-on experience with cGMP manufacturing processes for biologics, including upstream (cell culture, fermentation) and downstream (purification) operations. Expertise in aseptic processing, sterile manufacturing, and experience with single-use technologies is critical.
Regulatory Knowledge
Comprehensive knowledge of global regulatory requirements for biologics manufacturing (e.g., FDA, EMA, ICH guidelines). Proven track record of successfully navigating regulatory inspections and submissions.
Leadership & Management Skills
Demonstrated ability to lead, motivate, and develop large, diverse teams in a complex manufacturing environment. Exceptional strategic thinking, problem-solving, and decision-making capabilities.
Process Improvement
Strong background in operational excellence methodologies such as Lean Manufacturing, Six Sigma, or equivalent, with a track record of implementing successful process improvements.
Communication & Interpersonal Skills
Excellent written and verbal communication skills, with the ability to effectively interact with all levels of the organization, external partners, and regulatory bodies. Strong negotiation and influencing skills.
Financial Acumen
Proven experience in budget management, cost control, and capital expenditure planning for manufacturing operations.
Adaptability
Ability to thrive in a fast-paced, dynamic biotech environment, managing multiple priorities and adapting to evolving business needs.
Location
Ability to work on-site in the Boston, MA area and travel as required.
Benefits & Perks Offered
Our client offers a highly competitive executive compensation package designed to attract and retain top-tier talent. This includes a robust base salary, significant performance-based bonuses, and potential equity options. Comprehensive health benefits (medical, dental, vision) are provided, along with a generous 401(k) retirement plan with company matching.
Additional executive perks may include relocation assistance, executive health programs, ample paid time off, and opportunities for continuous professional development and leadership training. We are committed to fostering an environment where our leaders can thrive both personally and professionally, contributing to groundbreaking scientific advancements and enjoying a superior quality of life in one of the nation’s leading biotech hubs.
How to Apply
If you are a driven and experienced leader ready to take on this challenging and rewarding role as VP of Manufacturing (Biologics) in Boston, MA, we encourage you to apply. Please submit your resume and a detailed cover letter outlining your qualifications and experience relevant to this position through the JRG Partners career portal. We look forward to reviewing your application and discussing how your expertise can contribute to our client’s success. For more information on our specialized recruitment services in this sector, please visit our Life Sciences Recruitment page.
