Supervisor, Manufacturing

Job Summary

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.

This role offers a challenging career opportunity with competitive benefits in a performance‑recognizing environment.

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.

• Direct floor leadership for the manufacturing team and key value‑stream leadership for projects providing both technical and operational leadership and expertise.
• Solve or troubleshoot complex problems.
• Accountability for floor operations and execution, directly impacting product, patient and process.
• Provide leadership, management and company vision necessary to ensure proper controls, key performance indicators (KPIs), people and systems are in place within the manufacturing function.
• Work with department leadership and team to establish programs, practices and processes that drive a high‑performance culture and engaged workforce across safety, quality, delivery, cost and people.
• Escort vendors/visitors within MFG clean rooms.
• Lead all day‑to‑day manufacturing operating activities including but not limited to:
• Manufacturing.
• Manufacturing support.
• Manufacturing compliance to ensure delivery of departmental commitments, achieving company objectives.
• Batch record / logbook reviews and approvals.
• Review completion of MBRs; hand off to QA with accuracy, bringing MBRs to complete disposition.
• Create batch readiness task trackers and schedule MFG operations.
• Assist in planning, scheduling, and production functions to ensure adequate materials, equipment and personnel are available to meet the production schedule.
• Support and conduct enrollment of materials / bill of materials.
• Create purchase requests / procure items as needed.
• Encourage and enforce a culture of compliance and continuous improvement surrounding safety, quality, delivery, cost and people.
• Assist in the development and implementation of KPIs to track and lead successful, timely and achievable goals, objectives, and projects.
• Maintain department operational and capital budgets, driving financial results and optimization of fixed and variable costs.
• Work with internal stakeholders in manufacturing, process development, process sciences, project management, research and development to facilitate successful projects to manufacturing transition and management.
• Provide leadership, direction and accountability to ensure inspections, deviations, change control, CAPAs and regulatory commitments are met on time with the highest standards of quality and area ownership; may be required to author/draft these documents.
• Author/draft protocols when needed.
• Collaborate with team to develop a robust training program/strategy ensuring technician ownership and accountability.
• Work with team to develop and maintain operational excellence programs such as 6S, lean manufacturing and leadership standard work.
• Collaborate with all other entities on site including Process Development, Quality Assurance and Quality Control.
• Make decisions based on professional judgment, experience, budget, cGMP regulations and the ethical guidelines of good business practices.
• Evaluate functional strengths and continuous improvement opportunities within the GM manufacturing team and surrounding focus areas.
• Stay current with relevant technologies and be forward‑thinking to identify new approaches and opportunities.
• Minimum expectation of 40 hours per week unless otherwise dictated by management or business needs.
• Able to work the schedule…