Manufacturing Associate

Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.

For more information, visit our website at www.kincellis.com.

Essential Duties and Responsibilities

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. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Utilize proficiency in Microsoft Word, Excel, PowerPoint, and other relevant applications to support manufacturing operations.
• Apply knowledge of aseptic processing, cell culture, and cell therapy manufacturing within a cGMP-regulated environment.
• Maintain strict adherence to personal protective equipment (PPE) requirements to ensure a safe and compliant workspace.
• Collaborate with cross-functional teams to draft, revise, and maintain Standard Operating Procedures (SOPs).
• Perform Quality Control (QC) evaluations as part of in-process and final product assessments within the manufacturing environment.
• Demonstrate an understanding of material flow and proper disinfection procedures for transferring materials into cleanroom areas.
• Take personal responsibility for maintaining a safe work environment and completing all assigned training requirements on time.
• Partner with the Investigation team to support root cause analysis and corrective/preventive actions related to Quality and Safety incidents.
• Build foundational knowledge of GXP principles, including GMP, GLP, GCP, and GDP, and apply them to daily operations.
• Execute cleaning and sanitization procedures for manufacturing equipment and cleanroom facilities in compliance with SOPs.

Qualifications

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

Required:

• High school diploma or equivalent required; 0–2 years of relevant education and/or experience in a related field.
• Ability to work 40 hours per week, including weekends as needed.