Associate II, Manufacturing

About CTMC

      CTMC (Cell Therapy Manufacturing Center), a joint venture between Resilience and MD Anderson Cancer Center, is a first-of-its-kind biotech located in the world-renowned Texas Medical Center created to accelerate cell therapies moving from research to patients. CTMC develops and manufactures cell therapies invented at MD Anderson, as well as biotechs, including a variety of modalities such as CAR-T, TIL, ETC and TCR-T.  We aim to file 4 INDs in the first 12 months as we work closely with MDACC research and clinical faculty to bring impactful cell therapies to cancer patients. Our partnership with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in their first two years gives CTMC access to advanced technology and processes and enables us to stay at the cutting edge of biomanufacturing practices. Through the capabilities within CTMC and our alliance with MD Anderson Cancer Center and National Resilience, we co-develop cell therapy products with biotech companies and help them industrialize and accelerate their innovative therapeutics to reach the clinic quicker and ultimately maximize patient impact.    

     CTMC is housed in a state-of-the-art 60,000sqft development and manufacturing facility in the Texas Medical Center with an integrated team of 75 industry veterans and scientists with a depth of cell therapy expertise.  The unique structure of our joint venture with two highly established partners gives the organization financial stability and a long-term horizon, despite the current environment of funding uncertainty in the biotech field.  Our broad scope and novel corporate structure allow employees a plethora of development opportunities for members of our team.  We are passionate about aggressively bringing life-saving cures to patients and achieving it through a cohesive team-first culture and balanced work-life environment for our staff.  If you feel you can contribute to our mission and be part of a newly imagined biotech, we welcome your application. 

 Responsibilities

• Perform cleaning, kitting, documentation, processing, and materials procurement for the manufacturing department.
• Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
• Assist with training staff on proper operations and documentation in cGMP cleanroom facilities. 
• Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges. 
• Operate the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Incubators, Cell Stacks, Cobes, or Lovos.   
• Provide input to develop SOP’s for new and incoming equipment.
• Provide input and assistance in executing training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment. 
• Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
• Execute master batch production records in a timely manner and maintain accurate documentation with FDA’s Good Manufacturing Practices.
• Request and prepare materials for manufacturing operations while maintaining proper inventory levels in the cleanroom at all times.
• Assist support for routine maintenance activities.  
• Ensure transparent communication with staff, teams, support functions, and site leadership team.   
• Meet and report key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
• Other duties as assigned. 

Qualifications/Skills 

• Bachelor’s degree in scientific field, or equivalent education and experience.
• 2 yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required.
• 2 yr.’s experience in a related manufacturing environment (cell therapy or biotech) preferred.
• Previous experience with the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Cell Stacks, Cobes, or Lovos preferred.
• Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
• Previous GMP Experience preferred.
• Previous experience performing accurate calculations and lab measurements preferred.
• Able to understand and follow personnel flows, cleaning procedures, gowning requirements and other procedures defining requirements necessary to ensure cGMP compliant operations of cleanroom facilities. 
• Meticulous attention to detail in terms of documentation, following procedure SOPs, and performing functions as it pertains to the Batch Record. 
• Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.

Working Conditions, Equipment, Physical Demands 

Physical Demands-  

• Frequent standing, walking, sitting, and reaching required.
• Frequent lifting up to 10 lbs. required.
• Occasional lifting, pushing, and pulling up to 50 lbs. required.
• Frequent use of computer/keyboard required.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. 

The above job description is an overview of the functions and requirements for this position.  This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.