Location: Houston, TX (On-site)
Department: Quality Assurance
Reports to: Head of Quality Assurance
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
- Serve as a Quality Operations leader providing quality oversight and support for GMP manufacturing operations, ensuring compliance with regulatory requirements, company procedures, and quality standards.
- Perform and approve batch disposition decisions for raw materials, intermediates, and drug products, ensuring timely and compliant product release.
- Lead comprehensive review and approval of batch production records, laboratory records, and associated GMP documentation to ensure accuracy, completeness, and adherence to cGMP requirements.
- Manage quality records including deviations, CAPAs, change controls, investigations, and other quality system records, ensuring timely closure and effective resolution.
- Provide quality oversight of aseptic manufacturing operations, ensuring adherence to contamination control strategies, aseptic techniques, and GMP behaviors.
- Partner closely with Manufacturing, Quality Control, Supply Chain, Validation, and Technical Operations to proactively identify and resolve quality and compliance issues.
- Participate in quality review boards and cross-functional governance meetings, providing risk-based recommendations and quality leadership.
- Author, review, revise, and approve SOPs, work instructions, specifications, and quality system documents.
- Support inspection readiness activities and participate in regulatory inspections, customer audits, and internal audits.
- Drive continuous improvement initiatives focused on compliance, efficiency, quality metrics, and operational excellence.
- Support onboarding, training, mentoring, and development of Quality Operations team members.
- Perform other duties and responsibilities as assigned.
Qualifications & Skills
- Bachelor’s degree in a scientific discipline (Biology, Chemistry, Biochemistry, Biotechnology, or related field) required.
- Minimum of 5–7 years of Quality Assurance experience in a regulated pharmaceutical, biotechnology, or cell and gene therapy environment
- 1–3 years of supervisory or management experience preferred.
- Demonstrated leadership abilities with experience coaching, mentoring, and developing team members.
- Basic understanding of Cell and Gene Therapy manufacturing processes and quality systems preferred.
- Experience supporting Quality Assurance activities within manufacturing, quality control, and/or quality systems operations.
- Working knowledge of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and other applicable GxP regulations.
- Familiarity with applicable regulatory requirements, industry guidance documents, and quality standards.
- Effective interpersonal skills with the ability to collaborate across cross-functional teams.
- Excellent organizational skills and attention to detail.
- Ability to prioritize multiple tasks and manage competing deadlines in a fast-paced environment.
- Strong verbal and written communication skills.
- Strong analytical and problem-solving skills.
- Proficiency with Microsoft Office Suite and quality management systems (e.g., electronic document management systems, deviation and change control systems).
Working Conditions, Equipment, and Physical Demands
This position primarily operates in an office environment but may require periodic presence in manufacturing, laboratory, warehouse, and quality control areas to provide quality oversight and support.
Equipment Used
- Computer, printer, telephone, and other standard office equipment.
Physical Requirements
- Prolonged periods of sitting and working at a computer workstation.
- Ability to occasionally lift and move items weighing up to 15 pounds.
- Ability to gown and enter controlled manufacturing environments when required.
- Ability to perform activities within manufacturing suites, warehouse areas, and raw material storage areas as needed.
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 to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.