Manufacturing Associate II - Temporary Contract

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.

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As a Contingent Manufacturing Associate II on temporary assignment, 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 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 individuals like you who take pride in their work and look for successful outcomes. 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 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.

• Proficient in Microsoft Word, Excel, PowerPoint, and other applications.
• Knowledge of aseptic processing/cell culture/cell therapy manufacturing in a cGMP setting.
• Maintaining personal responsibility with Personal Protective Equipment (PPE)
• Collaborate with the team to produce Standard Operating Procedures (SOP) or Manufacturing Batch Records.
• Ability to perform Quality Control evaluations in a manufacturing setting.
• Demonstrate the ability of material flow into the manufacturing cleanroom, including disinfection.
• Be responsible for your own safety. Also, be accountable for meeting your own training responsibilities. 
• Collaborate with the Investigation team to investigate Quality and Safety incidents.
• Develop a knowledge of GXP procedures (GMP, GLP, GCP, GDP, etc.)
• Must have the ability to clean equipment and manufacture cleanrooms.
• Contribute to the team’s success by sharing knowledge.
• Review of Applicable Logbooks
• Support and Conduct Enrollment of Materials / Bill of Materials.
• Create Purchase Requests / Procuring Items as needed.
• Escort Vendors / Visitors into the cleanroom
• Conduct 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) with a minimum of 1+ years of relevant GMP manufacturing experience.
• Associate’s degree (AS) with a minimum of 2+ years of relevant GMP manufacturing experience.
• High School Diploma (or equivalent) with a minimum of 3+ years of relevant GMP manufacturing or regulated technical experience.
• Must be able to work 40 hours per week. Overtime will be required frequently to meet production needs .
• Ability to work independently and stay on task in a fast-paced environment without direct supervision. 
• Must be able to recognize when processes, procedures, equipment, products, materials, etc. are out of specification.
• Effective oral communication.
• Successful completion of visual acuity requirements, as applicable.
• Ability to work well with others in a collaborative team environment.
• Regular and reliable performance and attendance are required.
• Able to work in a rapidly changing climate – reacts well to change.
• Must be able to perform mathematical calculations such as converting milliliters to liters or grams to kilograms. Understand significant figures and rounding.
• Must be able to stand and/or sit for extended periods. 
• Manage your own time and professional development.  Be accountable for your own results and prioritized workflows.

Preferred:

• 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 1+ years of relevant GMP manufacturing experience.
• Associate’s degree (AS) in Life Sciences, Engineering, or related discipline with a minimum of 2+ 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.
• Experience working in cGMP cleanroom environments (ISO 5–8).
• Have knowledge of cell and gene therapy processing, the metric system, and scales.
• Knowledge to initiate and drive to completion deviations, change controls, and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.

• An equivalent combination of education and experience may be considered.

Travel Requirements

• Little to none

Location

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

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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.