Kincell Bio
Site Head of Manufacturing (Director/Sr. Director)
Kincell Bio, Gainesville, Florida, us, 32635
Overview
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) focused on streamlining CMC development, analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. We support 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 www.kincellbio.com. Position
Site Head of Manufacturing (Director/Sr. Director) located in Gainesville, Florida. The incumbent is responsible for all manufacturing and operational activities and for providing strategic direction and leadership to the full site organization. The Site Head of Manufacturing will help develop and manage the site master plan, including facility upfit and startup planning, and will establish operations teams and supporting systems during construction and CQV phases to enable on-time facility start-up. The ideal candidate has a proven track record leading a clinical cell and gene therapy manufacturing organization and experience with facility startup. Responsibilities
Develop and execute the site master plan and operate a cell therapy manufacturing facility to supply clients with early-stage clinical materials. Provide strong, collaborative leadership; work with the Site Quality Head to maintain high standards for safety and quality compliance; align staff with on-site strategy and goals. Develop the site budget and long-range plans; monitor client programs and production planning; track costs and financial metrics; implement measures to improve plant utilization and reduce costs. Ensure Engineering and Facilities capital project planning aligns with the site master plan; oversee capital projects to deliver new capabilities on time and within budget. Drive operational excellence, continuous improvement, and a risk-based approach to build a skilled site team. Cultivate a culture aligned with core values: Collaboration, Agility, Customer-focus, Integrity, Responsibility. Engage with internal stakeholders and third-party contractors during facility design and construction to ensure safe, compliant, and flexible designs that support manufacturing; ensure on-time startup. Hire direct-line reporting staff across Manufacturing, Process Engineering and Automation, Material and Production Planning, Inventory Control and Logistics; establish and resource all site functions and systems for safe, efficient operations. Management Responsibilities
Hire, recruit, coach, and train employees within the Gainesville Operations group. Ensure facilities structure supports growth and identify gaps; work with HR to hire and develop staff. Set expectations, provide feedback, and take action to ensure performance and goal attainment. Qualifications
Senior leadership experience in the Cell and Gene Therapy industry. Minimum 15 years in life science or regulated industry; 10+ years directing staff and overseeing operations at a cGMP manufacturing site. BS/MS in Biology, Chemistry, Engineering, or related science; equivalent combinations considered. Proven ability to build and lead high-performing operations teams; collaborative with Quality and cross-functional groups to enable compliant product supply. Direct experience with regulatory inspections; strong knowledge of US and global regulations (ICH Q10, 21CFR210&211, Eudralex Volume 4, EU Annex 1). Demonstrated leadership and decision-making skills; ability to communicate effectively at all levels. Preferred
Experience leading an early-stage Cell and Gene Therapy site. Experience with cGMP facility builds, CQV requirements and startup sequencing. Experience with multi-product cell and gene therapy facilities, containment, and contamination control. Travel
10%-20% travel. Location
Gainesville, FL site. Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or veteran status, in accordance with applicable laws. This policy applies to all terms and conditions of employment including hiring, promotion, termination, layoff, transfer, leaves of absence, compensation, and training. Note to Employment Agencies:
Kincell Bio values relationships with Recruitment Partners. We will only accept resumes from contracted partners; we are not responsible for fees related to unsolicited resumes.
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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) focused on streamlining CMC development, analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. We support 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 www.kincellbio.com. Position
Site Head of Manufacturing (Director/Sr. Director) located in Gainesville, Florida. The incumbent is responsible for all manufacturing and operational activities and for providing strategic direction and leadership to the full site organization. The Site Head of Manufacturing will help develop and manage the site master plan, including facility upfit and startup planning, and will establish operations teams and supporting systems during construction and CQV phases to enable on-time facility start-up. The ideal candidate has a proven track record leading a clinical cell and gene therapy manufacturing organization and experience with facility startup. Responsibilities
Develop and execute the site master plan and operate a cell therapy manufacturing facility to supply clients with early-stage clinical materials. Provide strong, collaborative leadership; work with the Site Quality Head to maintain high standards for safety and quality compliance; align staff with on-site strategy and goals. Develop the site budget and long-range plans; monitor client programs and production planning; track costs and financial metrics; implement measures to improve plant utilization and reduce costs. Ensure Engineering and Facilities capital project planning aligns with the site master plan; oversee capital projects to deliver new capabilities on time and within budget. Drive operational excellence, continuous improvement, and a risk-based approach to build a skilled site team. Cultivate a culture aligned with core values: Collaboration, Agility, Customer-focus, Integrity, Responsibility. Engage with internal stakeholders and third-party contractors during facility design and construction to ensure safe, compliant, and flexible designs that support manufacturing; ensure on-time startup. Hire direct-line reporting staff across Manufacturing, Process Engineering and Automation, Material and Production Planning, Inventory Control and Logistics; establish and resource all site functions and systems for safe, efficient operations. Management Responsibilities
Hire, recruit, coach, and train employees within the Gainesville Operations group. Ensure facilities structure supports growth and identify gaps; work with HR to hire and develop staff. Set expectations, provide feedback, and take action to ensure performance and goal attainment. Qualifications
Senior leadership experience in the Cell and Gene Therapy industry. Minimum 15 years in life science or regulated industry; 10+ years directing staff and overseeing operations at a cGMP manufacturing site. BS/MS in Biology, Chemistry, Engineering, or related science; equivalent combinations considered. Proven ability to build and lead high-performing operations teams; collaborative with Quality and cross-functional groups to enable compliant product supply. Direct experience with regulatory inspections; strong knowledge of US and global regulations (ICH Q10, 21CFR210&211, Eudralex Volume 4, EU Annex 1). Demonstrated leadership and decision-making skills; ability to communicate effectively at all levels. Preferred
Experience leading an early-stage Cell and Gene Therapy site. Experience with cGMP facility builds, CQV requirements and startup sequencing. Experience with multi-product cell and gene therapy facilities, containment, and contamination control. Travel
10%-20% travel. Location
Gainesville, FL site. Kincell Bio provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or veteran status, in accordance with applicable laws. This policy applies to all terms and conditions of employment including hiring, promotion, termination, layoff, transfer, leaves of absence, compensation, and training. Note to Employment Agencies:
Kincell Bio values relationships with Recruitment Partners. We will only accept resumes from contracted partners; we are not responsible for fees related to unsolicited resumes.
#J-18808-Ljbffr