Contingent Worker, Manufacturing Associate I

Kincell Bio, LLC•Gainesville, FL

3h•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. For more information, please visit our website at www.kincellbio.com. As a Contingent Manufacturing Associate I, you will be operating 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. 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. Patients need individuals who take pride in their work and look for successful outcomes. You will be operating cell and gene therapy process equipment of varying complexity with different processes in accordance with standard operating procedures.

Requirements

Bachelor of Science degree in Natural Sciences (i.e., Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 0-2 years of manufacturing experience required 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.
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.
Manage your own time and professional development. Be accountable for your own results and prioritized workflows.

Nice To Haves

Have knowledge of cell and gene therapy processing, the metric system, and scales.
cGMP clean room experience.

Responsibilities

Working knowledge of Word and Excel
Demonstrate Aseptic Qualification
Maintaining personal responsibility with Personal Protective Equipment (PPE)
Be a collaborator when a team develops Standard Operating Procedures or Manufacturing Batch Records
Conduct Quality Control analyses in a Manufacturing setting
Able to learn how to handle materials and bring them into a Manufacturing cleanroom.
Clean Equipment and Manufacturing Suite / Rooms
Be accountable for your own Safety. Also, be accountable for maintaining your own training requirements.
Collaborate with the Investigation team when investigating Quality and Safety Incidents
Author Minor Quality / Safety Incident Investigation (Deviations) and Minor CAPAs
Develop a knowledge of GXP procedures (GMP, GLP, GCP, GDP, etc.)
Must help with cleaning with Equipment and Manufacturing process rooms.
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