Manufacturing Support Specialist

Position: Manufacturing Support Specialist (contract)
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 or Sr.)

** 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:

** 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

** Additional Responsibilities by Level*
* +  
** MA II:
** Demonstrates increased independence, technical proficiency, and ability to serve as verifier; contributes to process improvements and troubleshooting.

+  
** Senior MA:
** May lead manufacturing runs, mentor junior staff, assist with training, and drive continuous improvement initiatives.

** Required Experience and

Education:

*
* ** _Manufacturing Associate II_*
* + Associate or Bachelor's degree in related scientific field

+ 2+ years of GMP or cell therapy manufacturing experience

** _Senior Manufacturing Associate_*
* + 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…