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 93+ 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 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
- Leads and oversees process development projects assigned by leadership with the goal to improve manufacturing processes for CAR-T, TILs and other T-cell therapies.
- Assess manufacturing processes supplied by prospective partner companies for suitability for GMP manufacture and identify any gaps.
- Design, plan and oversee execution of the experimental plans to optimize/refine manufacturing process for T-cell therapeutics.
- Manage, coach and develop reports.
- Participate in hands-on project execution as needed, serve as a resource/subject matter expert for the technical team. Assign and manage reports to complete projects and trains junior team members on T-cell therapy processing. Troubleshoot technical issues with the team as they arise in the lab and share best practices and lessons learned.
- Develop processes in alignment with the latest FDA guidance and regulations applicable to the generation and quality monitoring of T-cell therapy products to ensure rapid translation of developed procedures in the GMP lab.
- Drive internal tech transfers from process development to manufacturing team. Lead the team to produce a complete draft of the manufacturing batch record aligned with CTMC quality standards at the conclusion of the development campaign and trains manufacturing operators in preparation for the engineering runs.
- Provide technical assessment of various new cell therapy technologies and make recommendations on process decisions for GMP implementation.
- Coordinate execution of project deliverables to meet timelines.
- Maintain current knowledge of the T-cell manufacturing field and introduce relevant materials to continuously improve the current processes.
- Maintain thorough accurate, legible, and organized written and electronic records, including use of electronic lab notebook.
- Author or review protocols, technical reports and draft manufacturing batch records. Author or review process-related CMC sections of IND applications. Train team members on authorship of said documents and eventually delegates authorship.
- Prepare scientific presentations to report on the status of the work performed in the laboratory and speak in front of a group of scientists and leadership that may include external partners .
- Communicate effectively within the company with members of own team or other departments such as manufacturing, analytical development, quality control, regulatory affairs and project management.
- Interface with appropriate internal and external key stakeholders, work with other functions / departments to achieve project objectives.
- Other duties as assigned.
Qualifications/Skills
- Ph.D. in a related scientific/engineering field.
- 10+ yrs. experience in PD laboratory operations developing processes on various cell manufacturing platforms and closed systems for the development of T-cell therapy products.
- Strong knowledge in T-cell biology.
- 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 and staff.
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
- Able to operate as an effective tactical, as well as strategic thinker.
- Able to coach and influence junior level scientists and associates.
- Flexible to work outside of normal business hours (nights, weekends) as needed.
- Proficient with Microsoft Office Suite or related software.
Working Conditions, Equipment, Physical Demands
The incumbent in this position works in an office and lab environment. The incumbent in this position will use the following equipment and shall have the following physical demands:
Equipment-
- Computer, printer, telephone
- Laboratory equipment
Physical Demands-
- Occasional standing and walking required.
- Frequent sitting, reaching, and computer/keyboard usage.
- Occasional lifting, pushing, and pulling up to 10 lbs. required.
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.
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.