QC Specialist I

Location Onsite,Houston, TX, 77030,United States Job Category Quality Control, Microbiology Industry Biotechnology, Cell Therapy Employee Type FT Exempt Required Degree 4 Year Degree Department: Quality Control Reports to: Supervisor, 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 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. Responsibilities Support all day-to-day functions and perform routine analysis of in-process, finished product and stability samples as outlined in laboratory procedures. Demonstrate aseptic processing capability of samples for relevant tests. Participate in assay transfer and qualification studies. Perform microbiological media qualification, sterility, growth promotion and pH testing. Perform Environmental Monitoring (air, surface, and personnel) for the GMP controlled areas. Generate trend analysis for environmental monitoring. Demonstrate technical proficiency in analytical procedures including but not limited to thaw and culture of cryopreserved cells/cell lines, DNA isolation, cell counting, flow cytometry, etc. Author and revise Standard Operating Protocols (SOPs) for test methods, OMC protocols for equipment, and other documents requested by the supervisor. Assist supervisor in performing laboratory investigation procedures and interpreting OOS and OOT test results. Plan and coordinate with other departments to ensure continuous and timely testing of clinical and stability samples. Oversee shipment and testing of analytical samples at contract testing organizations. Take ownership responsibility of one of the Quality Control Laboratory functions to maintain, track and update QC management. Maintain and care of the laboratory equipment and perform good housekeeping activities. Complete all training requirements in a timely manner. Work with other departments providing applicable assistance and/or serving as a subject matter expert. Other duties as assigned. Qualifications/Skills Bachelor’s degree in Biological Sciences, Biotechnology or a related field required. 1+ yr.’s experience in an aseptic manufacturing environment (cell and gene therapy), preferably with experience in a Quality organization preferred, 0+ yr.’s required or equivalent combination of education and experience. Knowledge of cGMP and FDA regulations. Experience working with non-conformances and/or laboratory investigations. Experience in cell therapy analytical methods (biological and microbiological) is preferred. Ability to work both independently without supervision as well as be part of a team; excellent communication and interpersonal skills, is required. Ability to effectively plan and organize activities and prioritize task completion to meet assigned schedule and deadlines. Capable of working in a fast‑paced environment and communicating effectively with a diverse work group. Working Conditions, Equipment, Physical Demands The incumbent in this position works in and office environment. The incumbent in this position will use the following equipment and shall have the following physical demands: Equipment- Computer Printer Facsimile Telephone Laboratory Testing Equipment Physical Demands- Occasional standing and walking required Frequent sitting, reaching, and computer/keyboard usage Occasional lifting, pushing, and pulling up to 10 lbs. required 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. #J-18808-Ljbffr Kids for the Future