QC Specialist III

Job Description

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.

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Responsibilities:

We are seeking a highly skilled and detail-oriented Quality Control Specialist III with a strong background in cell-based assays, including molecular techniques and flow cytometry, to support quality testing of cell and viral therapy products. The ideal candidate will have hands-on experience in advanced molecular platforms, aseptic techniques, and cGMP-compliant analytical testing.

Perform analytical testing on cell and viral therapy products to assess quality, purity, and safety, ensuring compliance with regulatory standards.

Execute and interpret molecular assays, including Vector Copy Number (VCN), Replication Competent Virus (RCV), and Mycoplasma testing, utilizing PCR-based methodologies.

Demonstrate hands-on expertise with qPCR and ddPCR technologies, as well as automated DNA extraction platforms.

Conduct and analyze cell-based assays, with demonstrated proficiency in flow cytometry and associated analytical techniques.

Support method qualification (MQ) activities, including drafting and reviewing Standard Operating Procedures (SOPs), Forms (FRMs), and protocols.

Perform aseptic sample processing for analytical testing in accordance with Good Laboratory Practices (GLP).

Adhere to established laboratory quality control procedures, ensuring accurate and timely documentation of all testing activities per SOPs.

Perform equipment calibration, preventive maintenance, and maintain equipment logs to support a state of compliance.

Contribute to the development, revision, and continuous improvement of SOPs related to testing methods, equipment operation, and general laboratory practices.

Execute daily laboratory tasks to ensure alignment with production and testing schedules.

Conduct stability testing for cell therapy products and viral supernatants according to established protocols and stability programs.

Support laboratory investigations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) assessments, with appropriate documentation.

Assist in the execution of method, equipment, and process validation/qualification activities in compliance with ICH guidelines, cGMP, cGTP, and other applicable regulatory standards.

Participate in technology transfer activities, including method transfer and associated documentation.

Support reference standard characterization and contribute to data trending analyses.

Ensure laboratory readiness for internal audits and external regulatory inspections by maintaining compliance with applicable quality and regulatory standards.

Assist in inventory management activities to maintain uninterrupted laboratory operations.

Promote laboratory organization and cleanliness, ensuring adherence to 5S and continuous improvement principles.

Perform other duties as assigned to support departmental and company objectives.

Qualifications/Skills

Bachelor’s degree in a scientific discipline, or an equivalent combination of education and relevant experience.

Minimum of 3 years of experience in analytical testing within a Quality Control (QC) laboratory, including:

Molecular assays (e.g., qPCR, ddPCR)

Automated and manual cell count and viability assessments

Flow cytometry

ELISA or other immunoassays

Demonstrated expertise in at least one key assay category.

Strong proficiency in performing accurate laboratory calculations and unit conversions.

Prior experience in drafting or reviewing Standard Operating Procedures (SOPs) is preferred.

Proven ability to collaborate effectively within cross-functional, multidisciplinary teams.

Capable of executing planned laboratory activities independently with minimal supervision.

Self-motivated and proactive in taking on additional responsibilities.

Preferred: Experience with Laboratory Information Management Systems (LIMS), including configuration or workflow design to support QC operations.

Proficient in Microsoft Office applications (Excel, Outlook, Word, etc.).

Willingness and availability to work flexible hours to support time-sensitive testing aligned with manufacturing schedules.

Able to work effectively in a fast-paced environment and communicate clearly with diverse team members.

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.

Full-time