Location : Houston, TX (Onsite)
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 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.
Position Summary CTMC is seeking a LIMS Administration Specialist to drive the implementation, configuration, and sustained use of the Laboratory Information Management System (LIMS) to support GMP Quality Control (QC) testing. This role is critical to enabling digital transformation of QC workflows and ensuring compliant, efficient, and data-integrity-driven operations across the analytical testing lifecycle.
The successful candidate will bring hands-on experience in GMP QC environments, with deep knowledge of laboratory workflows, regulatory requirements (e.g., 21 CFR Part 11, data integrity, ALCOA+), and technical expertise in LIMS configuration, SQL, and built-in reporting tools. This individual will collaborate closely with QC scientists, QA, IT, and LIMS vendors to ensure the system supports method execution, sample management, batch release testing, and audit readiness.
Key Responsibilities - Lead and execute the end-to-end LIMS implementation for GMP QC testing, including system configuration, user acceptance testing (UAT), and validation.
- Configure LIMS workflows for sample receipt, testing, stability studies, method execution, batch release, and CoA generation, ensuring alignment with GMP QC operations, converting paper-based records into digital executable forms.
- Develop and maintain reporting tools to support routine QC reporting, trending, and batch release documentation.
- Write and optimize SQL queries to manage and analyze QC data from relational databases (e.g., SQL Server); ensure compliance with data integrity expectations.
- Collaborate with QC leads and QA to translate testing workflows, sample flows, and instrument integration needs into digital solutions.
- Develop and deliver role-based LIMS training for QC analysts, supervisors, and system administrators; maintain user access records and training documentation.
- Author and maintain LIMS-related documentation including User Requirements (URS), configuration specifications, SOPs, validation protocols (IQ/OQ/PQ), and change controls.
- Work closely with the Computer and Equipment Validation team to support validation activities per GAMP 5 principles; ensure system meets requirements for 21 CFR Part 11.
- Act as a QC data scientist by evaluating method variability and identifying potential biases introduced by associated instrumentation and software platforms (e.g., FlowJo, BD FACSuite), including both data acquisition and analysis workflows.
- Serve as a QC digital systems SME during audits and inspections; prepare and present system documentation and traceability matrices as needed.
- Drive continuous improvement initiatives to reduce manual data entry, streamline workflows, enhance right-first-time documentation, and improve turnaround times.
- Other duties as required.
Qualifications/Skills - Bachelor's degree or higher in Chemistry, Biology, or equivalent degree in a related science.
- 5+ yrs. related experience within a relevant field, preferably biotechnology or cell therapy industry or equivalent combination of education and experience.
- 2+ yrs. of LIMS configuration or administration experience (e.g., LabVantage, Element LIMS) is required; specific experience with L7 LIMS preferred.
- Previous experience implementing and administering training for LIMS required.
- Experience with bioinformatics tools, data pipelines, or structured programming (Python, DAX, Power Query M, VBA).
- Hands-on laboratory experience with cell-based, flow-cytometry based and/or molecular-based assays would be a plus.
- Demonstrated proficiency in Microsoft Excel, including formulas and expressions, and spreadsheet validation for GMP use.
- Strong understanding of GMP requirements, data integrity (ALCOA+ principles), and experience validating spreadsheets or digital systems.
- Excellent troubleshooting and analytical thinking skills; able to identify system issues and work cross-functionally to resolve them.
- Strong communication and documentation skills; ability to write and maintain SOPs and training materials.
- Capable of working independently in a fast-paced, regulated environment, including occasional flexible work hours to support manufacturing timelines.
- Demonstrated ability to collaborate effectively in a multi-disciplinary team.
- Able to carry out planned activities with minimal supervision.
- Shows initiative to take on additional responsibility.
- Proficient with Microsoft Office (Excel, Outlook, etc.).
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.
