Manufacturing Associate II

Job Description

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
Schedule : Tues-Fri | 12pm-10:30pm
Location : Stafford, TX (onsite)
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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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 (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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