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.
CTMC is looking for a highly motivated Project Leader with exceptional scientific and communication skills to support our Houston, TX development and manufacturing site. This position will be responsible for managing execution of cell therapy projects including cross-functional planning and execution, aligning scientific and therapeutic strategy, early phase development, CMC, and regulatory filing to enable accelerated FDA approval and patient access to life saving therapies. Prior experience leading and managing complex and cross-functional projects is required, and a strong understanding of CMC and drug development is preferred. This role will report to the Head of Project and Alliance Leadership.
- Directly manage multiple development projects, leading cross-functional teams through strategy, planning and execution of projects, and driving these projects to IND filing and first in human clinical trials.
- Project leadership will encompass cell therapy programs that are developed in collaboration with MDACC faculty and with biotechnology companies.
- Drive novel cell therapy projects through IND studies to first-in-human clinical trials; leading at least 2 programs to the clinic over the first 12 months.
- Coordinate development activities to assure a high-quality process and assays are ready for Manufacturing and QC on time.
- Oversee the transition from Development into Manufacturing and the execution of supportive engineering runs.
- Coordinate functional groups with Regulatory to generate pre-IND and IND submissions and those regulatory strategies are clearly communicated.
- Manage the alliance with partners developing innovative, curative cell therapies. Use scientific knowledge and thinking to propel projects through execution.
- Prepare, track and report project scope of work, project plans and budgets.
- Monitor project progress and ensure execution and accountability within the team.
- Proactively identify project issues, potential risks, and delays, and provide strategies for risk mitigation.
- Clearly and effectively communicate project progress and provide visibility to the project team, functional heads, senior management, and external partners.
- Contribute to the organizational and project governance structure:
- Provide visibility across projects and departments.
- Facilitate and support project transitions between departments to move projects from development space into the GMP environment and through IND submission.
- Other duties as required
- Bachelor’s degree or Master’s in engineering, science, or related field required, PhD preferred.
- 12+ yr.’s. of relevant work experience, including 6 years of project leadership/ management in cell therapy or closely related field or equivalent combination of education and experience.
- Demonstrate familiarity with Biologics development to IND, required.
- Previous experience with Cell Therapy manufacturing preferred.
- High-level of communication skills required, both written and verbal.
- Demonstrate organization, focus and diplomacy skills.
- Demonstrate high level of emotional intelligence and the ability to create a collaborative trusting team.
- Possess mindset focus on strategic thinking, data-driven decision making and effective communication.
- Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint.
- Previous experience with matrix project management and/ or agile project management is beneficial.
- Ability to work onsite as needed (remote candidates will be considered with some travel required 25% of the time), relocation preferred.
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:
- Prolonged periods of sitting at a desk and working on a computer
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.