Manufacturing Associate III

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.

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Kincell is seeking a highly motivated Associate III who will be a key contributor to a dynamic and collaborative Manufacturing team. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. As an Associate III, you will be operating automatic and manual cell therapy equipment with a variety of complexity in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies.

You will perform quality control analyses as required to complete in-process batches and identify variations. You will be trained in handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials.

As part of manufacturing operations, you will be a team member who is relied on to have a good understanding of procedures, techniques, tools materials, and equipment. Your work and decision-making will be team-based and will focus on the prioritization of workflows centered on the process and available resources. You will follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing.

You will contribute to the team’s success by sharing knowledge. Patients need colleagues like you who take pride in their work and look for successful outcomes. You will help ensure patients have the therapies they need when they need them. You will be operating cell therapy process equipment of varying complexity with different processes in accordance with standard operating procedures.

• Independently execute and oversee complex GMP manufacturing operations under approved SOPs and Master Batch Records (MBRs), serving as a senior technical resource on the manufacturing floor.
• Perform and lead high-risk and critical manufacturing steps, including complex aseptic manipulations, open processing, formulation, and final drug product fill activities.
• Demonstrate advanced proficiency with manufacturing equipment relevant to cell and gene therapy processing, including setup, execution, basic troubleshooting, and readiness verification.
• Act as a technical point-of-contact during GMP operations, supporting issue resolution, real-time decision-making, and escalation as needed.
• Maintain and demonstrate aseptic technique qualification and serve as a role model for cleanroom behavior, contamination control, and GMP discipline.
• Ensure manufacturing activities are executed Right-the-First-Time, identifying and correcting errors proactively before QA intervention.
• Perform and independently verify complex calculations (dilutions, yields, recoveries, volumes) and assess process outcomes for accuracy and compliance.
• Author and lead manufacturing deviations, including root cause analysis (5M / 5-Why), impact assessments, and proposed corrective actions, with QA partnership.
• Support and, when assigned, own manufacturing-driven Change Controls, including technical justifications, execution readiness, and implementation support.
• Support and execute CAPAs, ensuring actions are practical, effective, and sustainable on the manufacturing floor.
• Demonstrate strong application of Good Documentation Practices (GDP) across paper-based and electronic systems.
• Identify systemic risks, recurring issues, and process gaps, and proactively elevate improvement opportunities.
• Serve as a subject-matter resource during audits, inspections, and internal quality reviews as applicable.
• Serve as a Qualified Trainer for multiple tasks, equipment, or procedures, including aseptic qualification and complex manufacturing operations.
• Mentor Manufacturing Associate I and II personnel, providing technical coaching, feedback, and development support.
• Support onboarding, qualifications, and readiness of new hires and newly qualified associates.
• Contribute to the design, refinement, and continuous improvement of training curricula, OJTs, and qualification pathways.
• Provide day-to-day floor leadership, coordinating execution activities and supporting shift or campaign readiness in the absence of formal supervision.
• Collaborate cross-functionally with QA, MSAT, Engineering, Supply Chain, and QC to resolve issues and ensure execution readiness.
• Lead or significantly…