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Kincell Bio · 1 day ago

Site Head of Manufacturing (Director/Sr. Director)

Gainesville, FL

Full-time

Onsite

Director/Executive

15+ years exp

Kincell Bio is a contract development and manufacturing organization focused on cell and gene therapy. They are seeking a Site Head of Manufacturing to lead their facility in Gainesville, Florida, responsible for all manufacturing and operational activities, strategic direction, and establishing a high-performing operations team.

BiopharmaBiotechnologyPharmaceutical

Responsibilities

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

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

Qualification

CellGene TherapyCGMP ManufacturingRegulatory ComplianceOperations ManagementBudget DevelopmentLeadership ExperienceTeam BuildingContinuous ImprovementCommunication SkillsCollaboration

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