CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned 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, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.
In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.
Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and 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 mission.
At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. 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.
- Foster, lead and embed a strong culture of Quality throughout the organization.
- Lead the development, deployment and maintenance of programs, processes, and methods to ensure high quality products and compliance with cGMPs, including operational excellence, training, and effective documents controls.
- Provide guidance and support activities to ensure manufacturing facilities and support areas comply with applicable regulations and industry best standards.
- Develop and implement best practice quality improvement programs, policies, procedures, and processes.
- Lead and participate in projects within the organizations objectives and project timelines and participate in cross-functional projects as the quality subject matter expert.
- Collaborate with other leaders across the organization and assist in the continuous improvement.
- Represent quality assurance at various projects and technical meetings, as needed.
- Manage key quality metrics and resources to ensure compliant disposition of materials and cell therapy products.
- Monitor key quality indicators to identify potential risks and for supporting continuous improvement.
- Prepare and present periodic management updates on Department activities to Leadership.
- Train and motivate employees to Quality Service procedures and practices to ensure that quality standards are met.
- Manage a team of quality professionals to goal oriented tasks.
- Assist in the recruiting process.
- Other duties as required.
- Bachelor’s degree in a scientific field.
- 12+ yrs. related experience in manufacturing processes, QA, Operational Excellence and Training combined.
- 6+ yrs. managerial experience, preferably within QA.
- Understanding of Cell and Gene Therapies.
- Demonstrate expertise in multiple QA related areas; SME in specific areas related to systems.
- Understanding of cGMPs, GLPs.
- Knowledge of local and global regulations.
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent organizational skills and attention to detail.
- Excellent time management skills with a proven ability to meet deadlines.
- Strong analytical and problem-solving skills.
- Strong supervisory and leadership skills.
- Proficient with Microsoft Office Suite or related software.
Working Conditions, Equipment, Physical Demands
The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:
Equipment- Computer, printer, fax, and telephone.
Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable.
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.