Process Engineer I, Process Development

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

Play an important role in cell therapy cryopreservation process development projects with the goal to implement and improve quality and function of CAR-T, TILs and other cell therapies.

Participate in the design, planning and execution of process development experiments aimed at optimizing the cryopreservation, fill and finish of T-cell products for cancer immunotherapy.

Develop processes in alignment with regulatory guidelines to ensure rapid translation of developed procedures in the GMP lab.

Perform assays to define physical characteristics of the cells important for cryopreservation optimization utilizing specialized equipment such as a cryomicroscope or a cell analyzer

Assess and optimize cryoprotectant formulations to enhance product survival and performance.

Take initiative of troubleshooting problems as they arise in the lab and shares best practices and lessons learned with the team.

Execute project deliverables to meet timelines.

Assist with data analysis and interpretation of experiments to optimize freezing, thawing, and storage conditions for our cell therapies.

Maintain clear and rigorous experimental records, including electronic laboratory notebooks

Write protocols and technical reports.

Participate in Manufacturing Batch Record drafting and reviewing

Prepare scientific presentations to report on the status of the work performed in the laboratory and speak in front of a group of scientists and management.

Communicate effectively with lab members within the process development team and with stakeholders across different functions such as manufacturing, analytical development, quality assurance and regulatory affairs.

Other duties as assigned.

Qualifications/Skills

Bachelor in a related scientific/engineering field.

7+ years’ relevant experience, or Masters degree, preferably in the biotech industry or equivalent combination of education and experience.

Experience in Process Development laboratory operations with various cell manufacturing platforms including closed systems for the development of T-cell therapy products.

Strong knowledge in cell biology.

Experience in cryobiology is a plus.

Experience with microscopy, equipment temperature mapping, cryopreservation of immune cells in desirable.

Demonstrated ability to collaborate effectively in a multi-disciplinary team.

Demonstrated strong communication skills, interpersonal skills and a superior drive for results.

Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.

Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.

Able to operate with minimal supervision.

Proficient with Microsoft Office Suite or related software.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in a laboratory environment as well as 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

Laboratory equipment

Physical Demands-

Frequent standing and walking required.

Frequent sitting, reaching, and computer/keyboard usage.

Occasional lifting, pushing, and pulling up to 20 lbs. required.

This job may also require to operate in a cleanroom environment occasionally. The cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom attire; e.g. coat, bouffant, face mask, and gloves.

Must be able to stand or sit for extended periods. Must be able to wear personal protective equipment when 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.

Full-time