Associate I, Manufacturing - Temporary Worker

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.

As a Contingent Manufacturing Associate I, you will be responsible for operating both automated and manual cell therapy equipment of varying complexity to support CAR-T, CAR-M, or CAR-NK manufacturing processes, following established standard operating procedures and company policies. You will conduct quality control analyses to support in-process batch production and detect any process deviations. This role involves handling leukapheresis-derived cellular materials; therefore, you will receive comprehensive training in hazardous material handling and emergency response procedures.

As part of the manufacturing operations, you will be expected to demonstrate a strong understanding of procedures, techniques, tools, materials, and equipment used in the production process. Your role will involve team-based decision-making, with a focus on prioritizing workflows based on process requirements and available resources. You will follow standard operating procedures to carry out tasks that may vary in scope, complexity, and duration.

Patients are counting on dedicated professionals like you-those who take pride in their work and strive for meaningful results. In this role, you'll play a vital part in ensuring life-changing therapies reach the patients who need them, exactly when they need them most!

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.
• Ability to work independently and maintain focus in a fast-paced environment.
• Strong attention to detail, with the ability to recognize deviations in processes, procedures, equipment, materials, and products.
• Effective verbal communication skills.
• Proven ability to work collaboratively within a team-oriented environment.
• Consistent, reliable performance and attendance are essential.
• Adaptability to change and the ability to thrive in a dynamic, evolving work environment.
• Proficient in basic math, including unit conversions (e.g., milliliters to liters, grams to kilograms).
• Understanding of significant figures and proper rounding practices.
• Physically capable of lifting and pushing loads of 50+ pounds.
• Ability to stand or sit for extended periods as required by job duties.
• Capable of time management and personal accountability, with the ability to prioritize tasks.

Preferred:

• Bachelor’s degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (e.g., Chemical, Biomedical) with 0-2 years of relevant manufacturing experience.
• Hands-on experience working in a cGMP-compliant cleanroom setting.
• Familiarity with cell and gene therapy manufacturing processes, including use of the metric system and laboratory scales.

Travel Requirements

• Little to none

Location

• This is a 100% site-based position located at the Gainesville, FL site with occasional weekend work and overtime required.

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Kincellis Advanced Therapies 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. Kincellis Advanced Therapies 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: Kincellis Advanced Therapies 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.