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.
The Production Planner & Scheduler plays a pivotal role in developing, managing, and actively maintaining detailed production schedules for multiple client programs across complex technology platforms. You will forecast and secure critical raw materials, identify and mitigate bottlenecks/risks, and ensure alignment with client timelines, GMP requirements, and chain of identity/custody standards, driving on-time delivery in our CGT operations. You'll provide key site operations input for Sales & Operations Planning (S&OP) meetings and collaborate closely with manufacturing, process development, project management, and clients to resolve conflicts and optimize capacity.
Essential Duties and Responsibilities
Reasonable accommodation 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.
- Develop, maintain, and dynamically manage detailed production and campaign schedules for client programs, ensuring alignment with sponsor timelines, SOW milestones, and GMP/cGMP compliance in a patient-centric CDMO environment.
- Monitor and proactively adjust manufacturing and process development schedules; lead resolution of conflicts, capacity constraints, and scheduling risks to prevent delays in high-stakes CGT production.
- Lead raw material forecasting, planning, and supply monitoring for critical, expiration-sensitive, and long-lead-time items (e.g., viral vectors, plasmids, single-use consumables), mitigating supply risks to support uninterrupted schedules.
- Collaborate cross-functionally with manufacturing, process development, quality, project management, and clients to resolve raw material issues, prioritize campaigns, and maintain chain of custody/identity requirements.
- Participate in and contribute site operations insights to S&OP meetings, communicating production plans, highlighting potential issues, and proposing solutions to align supply chain with client demand and sales forecasts.
- Support technology transfers, maintain/update BOMs, and assist in demand planning for client campaigns.
- Drive continuous improvement in planning/scheduling processes, best practices, and tools to enhance efficiency, scalability, and risk mitigation as we grow.
Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
- Bachelor’s degree in Supply Chain, Operations Management, Business, Engineering, Life Sciences, or related field.
- 5+ years of experience in production planning and scheduling (preferred: in CDMO, biopharma, or GMP-regulated life sciences; cell/gene therapy experience highly desired).
- Proven expertise in high-visibility scheduling for clinical/commercial programs, including managing complex, variable timelines, client-facing coordination, and risk mitigation in CGT or similar high-mix/low-volume environments.
- Strong proficiency in ERP systems (MS Dynamics 365 a plus), advanced Excel, and planning tools (e.g., APS/MRP modules, scenario modeling).
- Excellent analytical, problem-solving, and prioritization skills; ability to thrive in a fast-paced, changing environment with shifting priorities.
- Outstanding communication and collaboration skills; comfortable interfacing directly with clients, manufacturing teams, and leadership.
- Knowledge of GMP/cGMP requirements, supply chain risk management, and S&OP processes.
- An equivalent combination of education and experience may be considered.
Physical Demands
- Adjusting or moving objects weighing up to 25lbs
- In the performance of the duties of this job, the employee is required to travel occasionally and drive a motor vehicle
Travel Requirements
Location
This position is 100% on-site in either Gainesville, FL
#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.
