Associate IV, Manufacturing

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

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.

• 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:
  Clini Macs 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.
• 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,…