Location: Houston, TX (Onsite)
Department: Technical Operations
Reports to: Manager, Equipment
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
- Lead CTMC’s compliance of 21 CFR 211 regulations for all equipment, including Manufacturing and Quality Control.
- Draft or review all validation documents related to CSV including User Requirement Specifications, Design Verifications, Qualification Protocols, and Validation Reports.
- Lead the integration, programming and automation of all CTMC’s MES and LIMS systems.
- Lead day-to-day, including weekends, operational support and troubleshooting activities involving automated equipment and process control systems.
- Assist in client audits when required.
- Assist with training staff on MES or LIMS systems.
- Establish a culture of continuous improvement, collaborative spirit, and dedication to safe workplace practices.
- Assist and support routine maintenance activities, if required.
- Work cross functionally among Manufacturing, Quality Control, Quality Assurance, IT and other departments as assigned.
- 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 Computer Science, Life Sciences, or Engineering.
- 9+ yr.’s experience in related role.
- 4+ yr.’s experience in a regulated manufacturing environment.
- Experience with IT infrastructure, digital systems, and software solution deployments for biopharmaceutical business operations.
- Previous experience with MES and LIMS preferred.
- Proficient with Microsoft Office: Word, Excel, Outlook and Teams.
- Previous GMP Experience preferred.
- Previous experience with audits preferred.
- Meticulous attention to detail in terms of documentation and following SOPs.
- Able to work a flexible schedule including nights, weekends, and holidays with short advance notice.
Working Conditions, Equipment, Physical Demands
The incumbent in this position works in an office, labs, and clean room environments. The incumbent in this position will use the following equipment and shall have the following physical demands:
Equipment-
- Computer
- Printer
- Facsimile
- Telephone
- Manufacturing equipment
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.