Location: Houston, TX
Department: Quality Control
Reports to: Associate Director, Quality Control
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 over 80 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 organization. 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.
Key Responsibilities:
The QC Manager will provide technical and operational oversight for analytical testing activities supporting clinical and pivotal-stage Cell and Gene Therapy (CGT) programs transitioning toward commercial readiness. This role will lead testing execution, ensure compliance with GMP requirements, and support method qualification and validation activities for advanced analytical platforms including flow cytometry, molecular assays, and ELISA.
The ideal candidate is a strong technical leader with demonstrated expertise in flow cytometry data analysis, molecular testing methodologies, and ELISA platforms within CGT manufacturing environments.
- Provide day-to-day supervision of QC analytical staff performance:
- Flow cytometry analysis (multicolor panels, CAR detection, phenotyping, functional assays).
- Molecular assays (e.g., qPCR/ddPCR, vector copy number, gene expression)
- ELISA-based potency and cytokine assays
- Ensure testing activities support clinical Phase I/II, pivotal, and commercial readiness programs.
- Oversee data review, trending, and technical evaluation to ensure data integrity and compliance with 21 CFR Part 211 and Part 11 requirements.
- Lead or support analytical method qualification and validation activities per ICH guidelines
- Support transfer of analytical methods from Development to QC.
- Participate in investigations, deviations, OOS/OOT events, and CAPAs related to analytical testing.
- Ensure proper documentation practices and adherence to internal SOPs and regulatory standards.
- Support regulatory inspections and client audits as SME for analytical platforms.
- Contribute to readiness for commercial-scale manufacturing and lifecycle management.
- Perform daily lab tasks and support adherence to production and testing schedules.
- Assist in the execution of method, equipment, and process validation/qualification activities in accordance with ICH guidelines, cGMP, cGTP, and other applicable regulatory standards.
- Support reference standard characterization and data trending.
- Ensure lab readiness for internal and external audits by maintaining compliance with regulatory and quality standards.
- Assist with inventory management to support uninterrupted laboratory operations.
- Maintain general laboratory organization, cleanliness, and compliance with 5S principles.
- Perform other duties as assigned to support department and company goals.
Qualifications/Skills
- Bachelor’s degree in science field required or equivalent combination of education and experience.
- 9+ years of experience in GMP QC laboratory within Cell and Gene Therapy or biologics manufacturing.
- Advanced experience in:
- Flow cytometry analysis (panel design, gating strategy, data interpretation)
- Molecular analytical methods (qPCR/ddPCR preferred)
- ELISA assay execution and data interpretation
- Demonstrated experience supporting pivotal-stage or commercial readiness programs.
- Direct experience in analytical method qualification and/or validation under GMP.
- Strong understanding of data integrity, electronic systems, and regulatory expectations.
- Experience supervising or mentoring technical staff preferred.
- Capable of working in a fast-paced environment and communicating effectively with a diverse work group.
Preferred Experience
- Experience supporting regulatory inspections (FDA, EMA).
- Experience with CAR-T or gene-modified cell therapy products.
- Familiarity with analytical lifecycle management and assay robustness improvement.
- Experience with LIMS or electronic data systems.
Core Competencies
- Strong technical troubleshooting skills
- Ability to interpret complex analytical datasets
- Leadership and team development
- Regulatory and compliance mindset
- Cross-functional collaboration (QA, AD, Manufacturing)
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 Scanner Telephone Lab Equipment
Physical Demands-
- Frequent sitting, standing, walking
- Carrying packages and moving bins and boxes, lifting up to 10 lbs.
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.
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