Manufacturing Associate; II

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.

Title:

Manufacturing Associate (II)

Schedule:

Mon-Fri | 2:30pm-11pm

Location:

Stafford, TX (onsite) Rate: $32-35/hr. + benefits Contract Length:
Through March 2027

What You'll Do:

As a Manufacturing Associate, you will play a key role in supporting manufacturing operations:

• 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

Additional Responsibilities by Level

• MA II:
  Demonstrates increased independence, technical proficiency, and ability to serve as verifier; contributes to process improvements and troubleshooting.

Required Experience and

Education:

Manufacturing Associate II

• Bachelor's degree in related scientific field
• 2+ years of GMP or cell therapy manufacturing experience

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.