Qa director [h1.location_city]

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 is focused 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 www.kincellbio.com.

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 :

Qualifications :

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

Required :

Preferred :

Travel Requirements

Location

#LI-Onsite

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 status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincell Bio complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

NOTE TO EMPLOYMENT AGENCIES : Kincell Bio values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.