CTMC (Cell Therapy Manufacturing Center), a joint venture between Resilience and MD Anderson Cancer Center, is a first-of-its-kind biotech located in the world-renowned Texas Medical Center created to accelerate cell therapies moving from research to patients. CTMC develops and manufactures cell therapies invented at MD Anderson, as well as biotechs, including a variety of modalities such as CAR-T, TIL, ETC and TCR-T. We aim to file 4 INDs in the first 12 months as we work closely with MDACC research and clinical faculty to bring impactful cell therapies to cancer patients. Our partnership with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in their first two years gives CTMC access to advanced technology and processes and enables us to stay at the cutting edge of biomanufacturing practices. Through the capabilities within CTMC and our alliance with MD Anderson Cancer Center and National Resilience, we co-develop cell therapy products with biotech companies and help them industrialize and accelerate their innovative therapeutics to reach the clinic quicker and ultimately maximize patient impact.
CTMC is housed in a state-of-the-art 60,000sqft development and manufacturing facility in the Texas Medical Center with an integrated team of 75 industry veterans and scientists with a depth of cell therapy expertise. The unique structure of our joint venture with two highly established partners gives the organization financial stability and a long-term horizon, despite the current environment of funding uncertainty in the biotech field. Our broad scope and novel corporate structure allow employees a plethora of development opportunities for members of our team. We are passionate about aggressively bringing life-saving cures to patients and achieving it through a cohesive team-first culture and balanced work-life environment for our staff. If you feel you can contribute to our mission and be part of a newly imagined biotech, we welcome your application.
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.