Site Head of Manufacturing; Director​/Sr. Director

Site Head of Manufacturing (Director/Sr. Director)

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Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch.

Kincell Bio focuses on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR‑T, TCR, TILs, Tregs and CAR‑NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance.

For more information, please visit our website at

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role‑related duties other than those contained in this document.

• The Site Head of Manufacturing is accountable for developing and executing the site master plan and operation of a cell therapy manufacturing facility in order to supply clients with early‑stage clinical materials.
• Provide strong and collaborative leadership to the organization, and together with the Site Quality Head establish and maintain high standards for safety and quality compliance. Develop and deliver site goals which support the company goals. Ensure the SLT is aligned with on‑site strategy, priorities, and tactical approaches to achieve strategy. Ensure all staff understand the mission, key deliverables, and are collaborating effectively and driving towards goals.
• Together with the SLT, develop the site budget and long‑range plans. Maintain close involvement in client program and production planning throughout the year, as changes occur and priorities shift. Continually track costs and analyze financial metrics and trends. Develop and implement measures to improve plant utilization and reduce costs as appropriate.
• Ensure Engineering and Facilities capital project planning and execution are aligned with site master plan. Maintain close oversight of site‑related capital projects to deliver new capabilities on plan and within budget.
• Drive a site‑wide philosophy of operational excellence, continuous improvement, and risk‑based approach to build and deliver a highly skilled operational site team.
• Cultivate a culture that supports our core values of Collaboration, Agility, Customer‑focus, Integrity, Responsibility.
• Closely engage with internal stakeholders and third‑party contractors throughout facility design and construction phases. Ensure the designs are safe, compliant, flexible, and supportive to manufacturing platform. Ensure on‑time and successful facility start‑up.
• Hire direct‑line reporting staff including, but not limited to, Manufacturing, Process Engineering and Automation, Material and Production Planning, Inventory Control and Logistics. Ensure all site functions and systems are established, implemented, and properly resourced to support safe, efficient, and compliant operations.

• Hire, recruit, coach, and train employees within the Gainesville Operations group.
• Continuously assess and ensure the appropriate facilities structure is in place to support growth.
• Identify gaps and ensure the proper hiring and development of employees with the support of Human Resources.
• Set expectations, provide feedback and coaching, and take necessary action to ensure appropriate performance and goal attainment.

• Previous experience in Senior Leadership role in Cell and Gene Therapy industry.
• Minimum of 15 years of experience in a life science, regulated industry (pharmaceutical or biotech); 10+ years of hands‑on experience directing staff and overseeing operations at a cGMP manufacturing site.
• BS/MS degree in…