QC Specialist IV

Location: Onsite Houston, TX
Department: Quality Control
Reports to: Sr. Manager, Quality Control

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 8 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.

Role Summary 

As CTMC advances its portfolio of cell therapy products across early- to late-stage clinical development, the Quality Control (QC) team continues to expand its analytical capabilities. We are seeking a QC Specialist IV with strong expertise in analytical method qualification and validation. This role is ideal for an experienced QC professional who can ensure that methods are scientifically sound, phase-appropriate, and compliant with regulatory expectations throughout the product lifecycle. The successful candidate will play a key role in advancing analytical readiness for clinical and commercial manufacturing.

Responsibilities

• Lead and execute analytical method qualification and validation activities for QC assays supporting the release and characterization of cell and gene therapy products. Ensure study design, execution, and reporting are compliant with ICH and FDA expectations.
• Apply subject matter expertise across key analytical platforms, including:
  • Flow cytometry for phenotyping, purity, and functional marker expression.
  • Molecular assays (qPCR/ddPCR) for vector copy number (VCN) determination.
  • Immunoassays such as IFN-γ ELISA for functional potency assessment.
  • Automated cell counting and viability using systems such as the Cellometer and NC-200.
• Design, author, and oversee analytical method qualification and validation in compliance with ICH guidelines.
• Partner closely with Analytical Development to ensure seamless and compliant transfer of analytical methods into QC.
• Author, review, and approve technical documents including SOPs, validation protocols, qualification reports, and analytical methods. Ensure scientific integrity and regulatory readiness of all deliverables.
• Provide SME-level guidance and training to QC analysts, fostering technical proficiency and consistency in execution.
• Support regulatory submissions, audits, and inspections by preparing method validation summaries, presenting data, and defending QC analytical approaches.
• Lead or contribute to laboratory investigations (OOS, OOT, deviations) with emphasis on method performance, data integrity, and scientifically justified root cause determination.
• Continuously monitor assay performance, trend analytical data, and implement improvements or requalification as needed.
• Ensure all QC analytical activities are conducted in full compliance with cGMP, ICH Q2(R2), and applicable global regulatory standards.
• Engage in external-facing technical discussions with partners, collaborators, and contract laboratories to align on analytical expectations, study designs, and data interpretations. Represent CTMC QC in cross-functional and partner project meetings with professionalism and scientific rigor.
• Other duties as required.

Qualifications/Skills

• Bachelor's degree in a scientific discipline (advanced degree preferred) with 5+ years of QC or analytical development experience in a GMP-regulated environment or equivalent combination of education and experience.
• Proven experience in analytical method qualification and validation, including protocol design, execution, and data interpretation.
• Hands-on expertise with flow cytometry, molecular assays (qPCR/ddPCR), ELISA, and automated cell counting and viability platforms.
• Demonstrated ability to function as a subject matter expert (SME) for QC analytical methods and provide technical leadership within cross-functional teams.
• Proficient in authoring and reviewing technical documentation, including SOPs, validation protocols, qualification reports, and investigations.
• Familiarity with Laboratory Information Management Systems (LIMS) and electronic data workflows to support data integrity and compliance is a.
• Strong understanding of regulatory guidelines (ICH, FDA, EMA) governing analytical method validation and QC operations.
• Excellent organizational skills with the ability to manage multiple priorities, projects, and timelines in a dynamic environment.
• Effective communication and collaboration skills, with the ability to engage confidently across diverse teams and external partners.
• Able to work flexible work hours to ensure continuity of manufacturing and release activities.

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-  

• 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.