Kincell Bio is seeking a Site Head of Manufacturing who will be responsible for establishing and leading Kincell Bio’s Cell and Gene Therapy manufacturing facility 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 be closely involved in developing and managing the site master plan including the initial facility upfit and start-up planning. The incumbent will establish the operations teams and supporting systems during the construction and Commissioning, Qualification and Validation (CQV) phases to enable on-time successful facility start-up. The ideal candidate has a proven track record in leading a clinical cell and gene therapy manufacturing organization as well as additional experience in other cross functional roles. Prior experience with a facility start-up is key with an established track record for successfully leading an organization from early stage through growth/expansion phases. The Site Head of Manufacturing leads the Site Leadership Team (SLT) and plays a critical role in network supply for Kincell Bio.

Essential Duties and Responsibilities

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 with 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. 

Management Responsibilities:

• 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.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. 

Required:

• Previous experience in Senior Leadership role in Cell and Gene Therapy industry
• A 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 Biology, Chemistry, Engineering, or related science field
• An equivalent combination of education and experience may be considered
• Demonstrated experience building and leading high performing operations teams
• Demonstrated leadership and partnership with Quality and cross-functional groups to enable uninterrupted and compliant product supply
• Direct experience with regulatory agency inspections. Expert knowledge and application experience of US and applicable global regulations including ICH Q10, 21CFR210&211, Eudralex Volume 4, EU Annex 1
• Proven leadership, with ability to carry out difficult decisions in a logical and rational manner
• Demonstrated ability to communicate effectively at all levels

Preferred:

• Previous experience leading an early-stage Cell and Gene Therapy site
• Direct experience with cGMP facility builds, CQV requirements and strategy, and start-up sequencing 
• Direct experience with multi product cell and gene therapy facilities with close understanding of containment requirements and contamination controls 

Travel Requirements

• 10%-20% travel

Location

• This is a site-based position located at the Gainesville, FL site.

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