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.

For more information, please visit our website at www.kincellbio.com.

 

 

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. 

 

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.

• 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 escalate 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 contribute to continuous improvement initiatives, process optimizations, and risk reduction efforts.
• Provide technical input and review for SOPs, MBRs, Work Instructions, and protocols, ensuring clarity, compliance, and execution feasibility.
• Support batch readiness activities, pre-campaign equipment verification, and post-campaign line or area clearance.

 

Qualifications

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

Required:

• Education and Experience (one of the following):
• Bachelor’s Degree (BS) in Natural Sciences (e.g., Biology, Chemistry, Life Sciences) or Engineering (Chemical, Biomedical, or related) with a minimum of 2+ years of relevant GMP manufacturing experience.
• Associate’s degree (AS) in Life Sciences, Engineering, or related discipline with a minimum of 3+ years of relevant GMP manufacturing experience.
• High School Diploma (or equivalent) with a minimum of 5+ years of relevant GMP manufacturing or regulated technical experience.
• Demonstrated ability to lead and execute complex GMP manufacturing operations independently.
• Must be able to work 40 hours per week. Overtime will be required frequently to meet production needs.
• Ability to adapt to changing priorities, production schedules, and operational demands.
• Strong proficiency in Microsoft Excel, Word, and PowerPoint for documentation, data review, investigations, and operational tracking.
• Strong written and verbal communication skills suitable for deviation authorship, technical discussions, and cross-functional collaboration.
• Proven ability to identify, investigate, and resolve manufacturing and compliance issues.
• Ability to meet physical requirements of the role, including lifting materials/media and standing or sitting for extended periods.
• Successful completion of visual acuity requirements, as applicable.

Preferred:

• B.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 3+ years of manufacturing experience.

• Experience working within electronic Quality Management Systems (QMS) (e.g., Veeva Vault) for deviations, CAPAs, training, and document control.
• Prior experience owning or leading Change Controls in a GMP manufacturing environment.
• Experience supporting regulatory inspections, audits, or client-facing reviews.
• Advanced experience in cell and gene therapy manufacturing, aseptic processing, or complex cell culture platforms.
• Demonstrated leadership in process improvement, risk assessments, or operational excellence initiatives.
• Experience working in cGMP cleanroom environments (ISO 5–8)

 

Travel Requirements

• Little to none

 

Physical Demands

• Adjusting or moving objects weighing up to 50lbs
• Vision Acuity Testing
• Use of a Face Mask

 

Location

• This is a site-based position located in Gainesville, FL, and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.

 #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.