About CTMC

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.

Responsibilities

• Develop efficient Quality Systems and Operationsto compliantly support cell therapy and viral vector manufacturing as a core competency for the Organization. Autologous cell therapies are a powerful new modality that holds the potential to cure cancer; however, they present challenges in the manufacture and Quality oversight due to the time pressure to release batches. Thus, the overall focus for this Leader is to develop a comprehensive, compliant and fit-for-purpose Quality system overarching internal development and GMP manufacturing and testing.
  • Further developing an established comprehensive Quality system, including materials controls; production systems; facilities, equipment and environmental validation and maintenance; internal/external audit program; deviation/CAPA; training; change control; and document control. We released 50 batches last year, are targeting 100 this year and more in the coming years. The Quality systems must scale with our expanding Operations.
  • Implement Veeva QMS to integrate with existing Veeva QualityDocs and RIMS implementation and support implementation of additional electronic systems including LIMS, ERP and EM.
  • Interact with Manufacturing, Development, QC, Regulatory and Project Management to actively support the Quality aspects of Project Development from preclinical through IND to clinical.
  • Develop approaches with all groups to increase our compliance and productivity. When done well compliance can enhance productivity and help find ways to reduce time spent on non-value-added activities and focus on the value-creating ones
• External Partner Relations: We work on partnered projects with both academic and biotech organizations. Our overall approach to Quality remains the same. We structure interactions with outside groups such that they have visibility into our operations, but that they don’t have formal oversite responsibilities (i.e., signing off on batch records or batch release). This distinction (from being a CMO) is critical to maintaining our independence and efficiency. The leader of this group will be responsible for interacting with outside Quality groups from our partners and providing such structure through formal Quality Agreements, but more so through establishing trusting relationships through displaying competency, compliance, and transparency.
• Design the Quality organization by positioning the current staff for success, while identifying gaps and recruiting key talent. The QA group currently has 10 team members and is expected to potentially increase over the next year. Create an organizational structure that is fit-for-purpose, allows talent development and cross-training and is robust. Promote a Quality Culture across the organization where compliance complements rigorous, science-based product development and manufacturing.
• Other duties as required.

Qualifications/Skills

• BS/MS in scientific field with 12+ years of experience in Quality of Biologics, cell therapy preferred, or equivalent combination of education & experience.
• 6+ yrs.+ in an upper-level management role leading a team, preferably in quality assurance.
• Balance an independent, compliant mindset to protect patient safety with our Mission to cure cancer in patients who have no other treatment options.
• Leadership capabilities to define, populate, manage, and develop a team.
• Demonstrated ability to collaborate effectively in a multi-disciplinary team.
• Demonstrated strong communication skills, interpersonal skills, and a superior drive for results.
• Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management, staff and outside organizations.
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
• Ability to operate as an effective tactical, as well as strategic thinker.
• Expected to be full-time, on-site.

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.