Manufacturing Associate II

About the role

Kelly Scientific is seeking an experienced Cell Therapy Manufacturing Associate to support a client developing therapies that make a meaningful impact on the lives of patients with cancer. The schedule for this role is Tues-Fri, 12pm-10:30pm, and is located in Stafford, TX (onsite). The rate for this position is $33-35/hr, and the contract length is 12 months.

Responsibilities

As a Manufacturing Associate, you will play a key role in supporting manufacturing operations. Core responsibilities include serving as operator and/or verifier for cell growth and manipulation procedures, performing manufacturing activities in compliance with FDA Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and standards including FACT, CAP, and CLIA.

• Serve as operator and/or verifier for cell growth and manipulation procedures, including cell enrichment, culture, cryopreservation, thawing, and washing
• Perform manufacturing activities in compliance with FDA Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and standards including FACT, CAP, and CLIA
• Adhere to ALCOA++ and cGDocP requirements while maintaining accurate, compliant documentation and batch records
• Ensure aseptic handling of reagents and cellular products to maintain sterility and integrity through final patient infusion
• Follow strict cleanroom gowning and environmental procedures (Grade A/B/C/D environments)
• Identify and document deviations/events, notify leadership and Quality in a timely manner, and support root cause investigations and CAPAs

Secondary responsibilities include performing calculations for cell viability, dilutions, and concentrations, completing required logs and documentation, and maintaining GMP cleanliness. Additional responsibilities by level (MA II) include demonstrating increased independence, technical proficiency, and ability to serve as verifier, contributing to process improvements and troubleshooting, and providing input on change controls and work instructions.

Requirements

The ideal candidate will have a Bachelor’s degree in a related scientific field and 2+ years of GMP or cell therapy manufacturing experience. Required competencies include independent working, clear and efficient communication, problem-solving, critical thinking, initiative, and organizational and prioritization skills.

• Independent Working: routine tasks with limited supervision; non-standard tasks with close supervision
• Communication: clear and efficient verbal and written communication; common courtesy; interaction mainly limited to own team (peers and supervisor)
• Problem Solving: ability to identify, deeply analyze and communicate problems; basic ability to develop suitable solutions
• Critical Thinking: basic reflection on standard processes; identification of basic need and room for improvement within own or narrow scope
• Initiative: high degree of initiative and intrinsic motivation to exceed basic expectations of own tasks and responsibilities
• Organizational & Prioritization Skills: basic organization skills required to structure own daily tasks according to predefined work packages, schedule and standard lab processes; prioritization in close interaction with supervisor

Benefits

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans, and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.