Location: Houston, TX (Onsite)
Department: Project and Alliance Leadership
Reports to: Head, Project and Alliance Leadership
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
CTMC is looking for a highly motivated Project Leader, with exceptional scientific, drug development, project management and communication skills to support the Project and Alliance Leadership team in Houston, TX. Project & Alliance Leadership (PAL) plays an important role in defining and delivering value to partners within the CTMC mission. PAL serves as a centralized leadership and coordination function that aims to integrate CTMC’s deep cell therapy scientific expertise with an industrial GMP cell therapy manufacturing capability. 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. This role involves managing multiple cell therapy programs, requiring careful coordination with both external partners and internal stakeholders. Prior project management experience and a strong understanding of CMC and/or drug development is required. This role will report to the Head of Project and Alliance Leadership.
Responsibilities:
- Directly manage multiple development projects, leading cross-functional teams through strategy, planning and execution of projects at the manufacturing site, 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/or with biotechnology companies.
- Target expectations would encompass leading at least 2 novel cell therapy projects through IND studies to first-in-human clinical trials over the first 12 months.
- Working with both internal and partner stakeholders to:
- 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 that regulatory strategies are clearly communicated
- Coordinate with MD Anderson clinicians to enable a transparent exchange of clinical data
- Prepare and track 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 external partners and CTMC as well as between CTMC departments (for example from development space into the GMP environment or through IND submission to clinical manufacturing)
- Other duties as required.
Qualifications/Skills:
- Bachelor’s or Master’s degree in engineering, science, or related field required, PhD preferred
- 12+ years 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).
- Experience in early to late phase human therapeutic (drug) development and Familiarity with Cell Therapy and/or Biologics development to IND required
- Experience with Cell Therapy manufacturing highly preferred
- Mindset focus on strategic thinking, data-driven decision making and effective communication
- Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint
- Experience with matrix project management and/ or agile project management is beneficial
- Experience with digital systems and/ or digital transitions, including programming, is beneficial.
- Experience working in a fast-paced, collaborative team environment
- Possess mindset focus on strategic thinking, data-driven decision making and effective communication
- Proficient in Microsoft Outlook, Teams, Project, Excel, SharePoint, and PowerPoint
- Experience with off the shelf or bespoke scheduling software/ solutions a plus
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.
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.