Contingent Worker, Manufacturing Associate I
On-siteGainesville, Florida, United States
Job Summary
Operate automatic and manual cell and gene therapy equipment for CAR-T, CAR-M, or CAR-NK processes while performing quality control analyses to complete in-process batches. Maintain personal protective equipment, clean manufacturing suites and rooms, and escort vendors into clean areas. Collaborate on developing standard operating procedures, batch records, and minor quality or safety incident investigations. Support material enrollment, create purchase requests, and conduct post-campaign line clearances. Work 40 hours per week in Gainesville, FL, including early mornings, late evenings, and weekends, while adhering to GXP procedures and hazardous material handling protocols.
Required Qualifications
- Bachelor of Science degree in Natural Sciences (i.e., Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.)
- 0-2 years of manufacturing experience
- Equivalent combination of education and experience
- Ability to work 40 hours per week
- Ability to work independently and stay on task in a fast-paced environment without direct supervision
- Ability to recognize when processes, procedures, equipment, products, materials, etc. are out of specification
- Proof of passing a visual acuity test within the past year
- Effective oral communication
- Ability to work well with others in a collaborative team environment
- Regular and reliable performance and attendance
- Ability to react well to change
- Ability to perform mathematical calculations such as converting milliliters to liters or grams to kilograms
- Understanding of significant figures and rounding
- Ability to lift bags and/or containers of media
- Ability to stand and/or sit for extended periods
- Manage your own time and professional development
- Accountability for your own results and prioritized workflows
- Demonstrate Aseptic Qualification
- Maintaining personal responsibility with Personal Protective Equipment (PPE)
- Able to learn how to handle materials and bring them into a Manufacturing cleanroom
- Be accountable for your own Safety
- Accountability 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
Desired Qualifications
- Have knowledge of cell and gene therapy processing
- Have knowledge of the metric system and scales
- cGMP clean room experience
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