Temporary Worker, Manufacturing Associate

Overview

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

• As a Contingent Manufacturing Associate I, you will operate automatic and manual cell and gene therapy equipment with a variety of complexities 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.
• You will follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing.
• You will operate cell and gene therapy process equipment of varying complexity with different processes in accordance with standard operating procedures.
• Maintain personal responsibility with Personal Protective Equipment (PPE) and be a collaborator when a team develops Standard Operating Procedures or Manufacturing Batch Records.
• Contribute to the team’s success by sharing knowledge and review applicable logbooks.
• Conduct Quality Control analyses in a manufacturing setting and support enrollment of Materials / Bill of Materials as needed.
• Assist with cleaning of Equipment and Manufacturing process rooms and clean equipment and manufacturing suites/rooms.
• Be accountable for your own safety and maintaining your training requirements; collaborate with the Investigation team when investigating quality and safety incidents; author minor quality/safety incident investigations (deviations) and minor CAPAs.
• Develop knowledge of GXP procedures (GMP, GLP, GCP, GDP, etc.).
• Assist with purchasing requests and procuring items as needed; escort vendors/visitors into the cleanroom; contribute to enrollment of materials as needed.
• Support and conduct line or area clearances after campaigns.

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

• Required
• Bachelor of Science degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (Chemical, Biomedical) and 0-2 years of manufacturing experience or equivalent combination of education and experience.
• Must be able to work 40 hours per week.
• 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.
• Hiring will be contingent on passing a visual acuity test. Proof of passing a visual acuity test within the past year will be accepted.
• Effective oral communication and 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; understands significant figures and rounding.
• Must be able to lift bags and/or containers of media; must be able to stand and/or sit for extended periods.
• Ability to manage your own time and professional development; be accountable for your own results and prioritized workflows.

• Preferred
• Knowledge of cell and gene therapy processing, metric system, and scales.
• cGMP clean room experience.

• Vision Acuity Testing
• Use of a face mask

• None

• This is…