Manufacturing Associate II - Temporary Contract

Kincell Bio, LLC•Gainesville, FL

1d•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
Perform quality control analyses as required to complete in-process batches and identify variations.
Handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials.
Have a good understanding of procedures, techniques, tools, materials, and equipment.
Work and decision-making will be team-based and will focus on the prioritization of workflows centered on the process and available resources.
Follow standard operating procedures to complete tasks which may vary in scope, complexity, and timing.
Contribute to the team’s success by sharing knowledge.
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.
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.
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.