Manufacturing Associate II

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.

Location: Stafford, TX (onsite) | Schedule: Tues–Fri, 12pm–10:30pm | Rate: $34–35/hr | Contract Length: 12 months

Core Manufacturing Responsibilities

• 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
• Work productively in a highly collaborative, creative, and fast-paced manufacturing environment

Secondary / Operational Support Functions

• Independently perform calculations for cell viability, dilutions, and concentrations
• Complete required logs, trackers, and documentation accurately
• Maintain GMP cleanliness (autoclaving, waste handling, facility organization)
• Support donor evaluation knowledge, screening/testing requirements, labeling, product acceptability, and release criteria
• Support validation and study activities (IQ/OQ/PQ)
• Provide input on change controls, work instructions (WIs), SOPs, deviations, OOS/OOE investigations, reports, and CAPAs
• Perform routine equipment maintenance and troubleshooting
• Prepare and present manufacturing summaries, as applicable
• May lead manufacturing runs, mentor junior staff, assist with training, and drive continuous improvement initiatives

Required Experience and Education

• Bachelor's degree preferred
• 4+ years of GMP or cell therapy manufacturing experience
• Demonstrated technical leadership and advanced troubleshooting capability

Competencies

• 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.
• Coachability — receive pre-defined trainings essential for area of responsibility; high responsiveness to constructive criticism and basic ability to autonomously reflect on required improvements; timely implementation of suggested improvements.
• Leadership Skills, Training & Supervision — basic leadership skills required for on-the-job trainings and guidance/support of (new) team members (e.g. providing and receiving feedback, empathy, honesty, reliability); train, instruct and coordinate E level; train D & C level during onboarding.

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. The following benefits reflect Kelly's general offerings; eligibility may vary by assignment, location, and job type.

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability
• Retirement savings plan
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)
• Transit spending account
• Paid sick leave under the applicable state or local plan