Associate IV, Manufacturing

Location: Houston, TX (Onsite)
Department: Manufacturing
Reports to: Manager, Manufacturing

About CTMC 

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.     

Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.     

Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals.     

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. 

Responsibilities

• Perform cleaning, kitting, documentation, processing, and materials procurement for the manufacturing department.
• Request and prepare materials for manufacturing operations while maintaining proper inventory levels in the cleanroom at all times.
• Maintain aseptic technique during processing to ensure quality and integrity of cellular drug products.
• Execute master batch production records in a timely manner and maintain accurate documentation with FDA’s Good Manufacturing Practices.
• Performs error free calculations, including but not limited to cell doses, dilutions, and total cell count or total viable cell count numbers.
• Train staff on proper operations and documentation in cGMP cleanroom facilities; including but not limited to Gowning Qualifications and Aseptic Process Simulation for new hires.
• Provides input in creating training programs and executes training for cleanroom personnel cGMP, best practices and awareness training related to working in a cleanroom environment.
• Train and lead junior level Associates on all aspects of the manufacturing process for which the individual is an SME.
• Provide input on manufacturing process optimization based on working knowledge and understanding of project for which individual is an SME.
• Operate standard cleanroom equipment: Incubators, BSCs, and Centrifuges.
• Operate the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Waves/Xuris, Incubators, Cell Stacks, Cobes, or Lovos.   
• Develop and create new SOPs for new and incoming equipment.
• Troubleshoot cell processing operations and equipment.
• Leads SOP revisions and creates new SOPs and batch records from equipment manuals and transfer documents for tech transfers.
• Participates in process transfer and optimization activities in conjunction with Process Development department.
• Writing deviations, CAPAs, Root Cause Analysis, or Change Controls. 
• Utilize various computer systems and databases to enter, retrieve and compile data.
• Coordinates with various departments, such as QA, QC, Material Management, Process Development, and Project Management when required to ensure deadlines are met. 
• Establishes a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices. 
• Assists support for routine maintenance activities.  
• Ensures transparent communication with staff, teams, support functions, and site leadership team.   
• Establishes, drives and reports key performance indicators in alignment with Cell Therapy Manufacturing and CTMC goals. 
• Other duties as assigned.  

Qualifications/Skills

• B.S. preferred, or equivalent education and experience.
• 5 yr.’s experience in a related manufacturing environment (cell therapy or biotech) required.
• 5 yr.’s experience with standard cleanroom equipment: Incubators, BSCs, and Centrifuges required. 
• Previous experience with one or more of the following Cell Therapy equipment: CliniMacs Prodigies, G-Rexes, Cell Stacks, Cobes, or Lovos required. 
• 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.
• Technical writing skills are required. 
• Proficient with Microsoft Office: Word, Excel, Outlook, PowerPoint, and Teams.
• Previous GMP Experience required.
• Previous experience with training junior and peer team members.
• Able to work late nights, weekends, and holidays with very short advance notice.
• Excellent communication skills, both written and verbal.

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.