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. 

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• 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

Qualifications

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 (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.

Preferred:

• Have 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

Travel Requirements

• None

Location

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

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