QC Specialist I

Resilience Texas LLC•Houston, TX

44d•Onsite

About The Position

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. The Quality Control (QC) Specialist I is responsible for conducting environmental monitoring (EM) and safety testing to support aseptic production and final drug product release. This role ensures compliance with Good Manufacturing Practices (GMP) and regulatory standards, contributing to the overall quality and integrity of the manufactured products.

Requirements

Bachelor’s degree in Biological Sciences, Biotechnology or a related field required.
1+ yr.’s experience in a quality control laboratory including knowledge of environmental monitoring, microbiological testing, and GMP requirements preferred, 0+ yr.’s required or equivalent combination of education and experience.
Proven capability to work aseptically in cleanroom environments.
Demonstrated ability to collaborate effectively in a multi-disciplinary team.
Able to carry out planned laboratory activities with minimal supervision.
Shows initiative to take on additional responsibility.
Proficient with Microsoft Office (Excel, Outlook, etc.).
Able to work flexible work hours to maintain critical testing during manufacturing runs.
Capable of working in a fast-paced environment and communicating effectively with a diverse work group.

Responsibilities

Perform routine environmental monitoring of air, surfaces, and personnel, including sampling using contact plates, viable and non-viable particulate sampling in classified aseptic production areas.
Analyze collected samples for microbial contamination, or other relevant parameters. Interpret data and document findings in accordance with company procedures and regulatory requirements.
Manage data entry, reporting and review of EM data within an electronic EM system.
Perform microbial identification of isolated organisms.
Execute media fill simulation in aseptic environments.
Ensure timely receipt and submission of samples within the organization.
Support the qualification of cleanroom facilities and assist with annual shutdown and restart programs.
Perform sterility testing, endotoxin analysis, Gram staining, and basic biochemical testing.
Execute growth promotion and pH testing for microbiological media.
Conduct stability testing as per protocols for cell therapy and viral supernatant products.
Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines.
Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations.
Perform basic maintenance, calibration, and quality control of laboratory equipment.
Maintain inventory and order laboratory supplies as needed.
Other duties as required.