Manufacturing Associate II

Vita Global Sciences, a Kelly Company; Stafford (TX); On-site; USD 97,424,000 - 100,289,000; Full time

Job summary

Kelly Scientific is seeking an experienced Manufacturing Associate II to support a client developing cancer therapies in Stafford, TX. The role is onsite with a Tue-Fri, 12pm-10:30pm schedule and a rate of $34-35/hr.

You will work in a GMP/cGTP environment, handling cell growth, culture, and product release under strict quality controls. The position requires 4+ years of GMP or cell therapy manufacturing experience, technical leadership, and the ability to troubleshoot independently.

Qualifications

• 4+ years of GMP or cell therapy manufacturing experience.
• Demonstrated technical leadership and advanced troubleshooting capability.
• Independent working with limited supervision.

Responsibilities

• Operate and/or verify cell growth and manipulation procedures.
• Maintain compliant documentation and batch records (GLP, GMP, GTP).
• Ensure aseptic handling and sterility through final patient infusion.
• Follow cleanroom gowning and environmental procedures.
• Lead small manufacturing runs and train junior staff.

Skills

GMP manufacturing

Cell therapy manufacturing

Leadership

Communication

Problem solving

Job description

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.

Title: Manufacturing Associate II

Schedule: Tues-Fri | 12pm-10:30pm

Location: Stafford, TX (onsite)

Rate: $34-35/hr.

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:

• 4+ years of GMP or cell therapy manufacturing experience
• Demonstrated technical leadership and advanced troubleshooting capability
• 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.