Contingent Worker, Manufacturing Associate I

About the role

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.

Your work will be team-based, focusing 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.

Responsibilities

• Operate cell and gene therapy process equipment of varying complexity in accordance with standard operating procedures.
• Demonstrate aseptic qualification and maintain personal responsibility with Personal Prote Equipment (PPE).
• Collaborate with the team to develop Standard Operating Procedures or Manufacturing Batch Records.
• Conduct Quality Control analyses in a manufacturing setting.
• Handle materials and bring them into a manufacturing cleanroom.
• Clean equipment and manufacturing suite/rooms.
• Be accountable for your own safety and maintain your own 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 cleaning equipment and manufacturing process rooms.
• Contribute to the team’s success by sharing knowledge.
• Review applicable logbooks.
• Support and conduct enrollment of materials/bill of materials.
• Create purchase requests/procure items as needed.
• Escort vendors/visitors into the cleanroom.
• Conduct post-campaign line or area clearance.
• Work with Word and Excel.

Requirements

• Bachelor of Science degree in Natural Sciences (e.g., Biology, Chemistry) or Engineering (Chemical, Biomedical, etc.) and 0-2 years of manufacturing experience, or 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.
• Must be able to recognize when processes, procedures, equipment, products, or materials are out of specification.
• Hiring contingent on passing a visual acuity test; proof of passing within the past year will be accepted.
• Effective oral communication skills.
• Ability to work well with others in a collaborative team environment.
• Regular and reliable performance and attendance.
• Able to work in a rapidly changing climate and react well to change.
• Must be able to perform mathematical calculations (e.g., converting milliliters to liters or grams to kilograms), understand 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.

Preferred Qualifications

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

Physical Requirements

• Vision acuity testing.
• Use of a face mask.
• Ability to lift bags/containers of media.
• Ability to stand and/or sit for extended periods.

Schedule

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