Kelly Scientific is seeking (2) Manufacturing Associates for full-time positions with a client developing therapies that make a meaningful impact on the lives of patients with cancer.
 
 Title: Manufacturing Associate (I, II or Sr.)
Schedule: Mon-Fri | 8am-5pm or 12:30pm-9pm ? 
Location: Stafford, TX (onsite)? 
Rate: $32-35/hr. + benefits
? 
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 I 

• Associate degree (or enrollment) in Biology, Biotechnology, Biomanufacturing, or related field 

• 0–2 years of relevant experience 

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 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. 

 
Comprehensive Benefits:? 

• Competitive rates for Health, Dental, and Vision Insurance 

• 4 weeks of Paid Time off, granted up front each year and prorated for first and last year of employment. 

• Sick Time Off – 56 hours  

• 12 Paid Holidays  

• 100% Employer-Paid Life Insurance?up to at 1x annual salary, up to one hundred thousand (club together) 

• 100% Employer Paid Short- and Long-Term Disability Coverage? 

• 401(k) with Immediate Eligibility? & company match… 

• You are eligible for 401(k) plan participation as of your first paycheck. 

• The company will match 100% of your contributions up to 3% of your base salary for the first two years of employment, 4% for years 2-3 of employment, and up to 5% of your salary from the fourth year onward of continued employment. 

• Partially paid Parental Leave?for eligible employees. (3 weeks) 

• Additional voluntary employee paid coverages including  Accident, Hospital Indemnity, and Critical Illness?Employee Paid Identity Theft Protection and Pet Insurance.  

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