Manufacturing Associate I

About the role

Kelly Scientific is seeking a skilled Manufacturing Associate to support a client developing innovative therapies for cancer patients. The schedule for this role is Monday to Friday, 7am-3:30pm, and is located in Stafford, TX (onsite). The rate for this position is $32-33/hr, and the length of the assignment is 8 months.

Responsibilities

As a Manufacturing Associate, you will play a key role in supporting manufacturing operations. Your core responsibilities will include:

• Serving as operator and/or verifier for cell growth and manipulation procedures, including cell enrichment, culture, cryopreservation, thawing, and washing
• 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
• Adhering to ALCOA++ and cGDocP requirements while maintaining accurate, compliant documentation and batch records
• Ensuring aseptic handling of reagents and cellular products to maintain sterility and integrity through final patient infusion
• Following strict cleanroom gowning and environmental procedures (Grade A/B/C/D environments)
• Identifying and documenting deviations/events, notifying leadership and Quality in a timely manner, and supporting root cause investigations and CAPAs

In addition to your core responsibilities, you will also be expected to perform secondary and operational support functions, including:

• Independently performing calculations for cell viability, dilutions, and concentrations
• Completing required logs, trackers, and documentation accurately
• Maintaining GMP cleanliness (autoclaving, waste handling, facility organization)
• Supporting donor evaluation knowledge, screening/testing requirements, labeling, product acceptability, and release criteria
• Supporting validation and study activities (IQ/OQ/PQ)
• Providing input on change controls, work instructions (WIs), SOPs, deviations, OOS/OOE investigations, reports, and CAPAs
• Performing routine equipment maintenance and troubleshooting
• Preparing and presenting manufacturing summaries, as applicable

Requirements and Qualifications

To be considered for this role, you will need:

• An Associate degree (or enrollment) in Biology, Biotechnology, Biomanufacturing, or related field
• 0–2 years of relevant experience

In addition to these requirements, you will also need to demonstrate the following 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

Benefits

As a Kelly employee, you will have access to a range of benefits, including:

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