Intern, Quality Control LIMS Specialist

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.

Responsibilities

CTMC is seeking a highly motivated and technically proficient person to support the implementation and ongoing configuration of the L7 LIMS platform within our GMP-regulated Quality Control (QC) laboratories. This role is critical to the digital transformation of analytical operations supporting cell and gene therapy manufacturing. The ideal candidate will possess a strong blend of technical expertise in scripting languages and a good understanding of regulated QC laboratory processes.

Key Responsibilities:

• Collaborate with internal stakeholders to gather user requirements and translate them into functional digital workflows within the L7 LIMS platform.

• Support design and implementation of assay-specific workflows, including configuration of sample lifecycle, metadata capture, testing specifications, result entry interfaces, and final result logic.

• Develop custom formulas and statistical logic for automated result calculation, trending, and pass/fail evaluation.

• Build reusable workflow components, including templates and calculation engines, that support standardization and data integrity across QC operations.

• Support configuration of QC test methods within the LIMS, integrating unit management, acceptance criteria, control charting, and other analytical attributes.

• Write and implement custom code (e.g., JavaScript, Python, or other supported scripting languages) to enhance or automate LIMS functionality per user and system requirements.

• Support validation and documentation efforts in accordance with 21 CFR Part 11, Annex 11, and applicable GAMP guidance.

• Participate in LIMS user training, troubleshooting, and change control processes.

• Other duties as required.

Qualifications/Skills

• High School Diploma required; enrollment in a Bachelor’s degree program in a relevant field preferred.

• Hands-on experience with coding and scripting to support LIMS automation and customization is preferred.

• Familiarity with LIMS configuration, assay design, and workflow management.

• Able to work in a fast-paced environment.

• Demonstrated ability to be nimble, collaborative, and eager to contribute.

• Excellent verbal and written communication skills with strong attention to detail.

• Prior involvement in LIMS validation and computer system validation (CSV) documentation is a plus.

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, telephone, and laboratory testing equipment

Physical Demands-

• Occasional standing and walking required

• Frequent sitting, reaching, and computer/keyboard usage

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