Scientist I, Analytical Development

About CTMC

CTMC (Cell Therapy Manufacturing Center), a joint venture between Resilience and MD Anderson Cancer Center, is a first-of-its-kind biotech located in the world-renowned Texas Medical Center created to accelerate cell therapies moving from research to patients. CTMC develops and manufactures cell therapies invented at MD Anderson, as well as biotechs, including a variety of modalities such as CAR-T, TIL, ETC and TCR-T. We aim to file 4 INDs in the first 12 months as we work closely with MDACC research and clinical faculty to bring impactful cell therapies to cancer patients. Our partnership with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in their first two years gives CTMC access to advanced technology and processes and enables us to stay at the cutting edge of biomanufacturing practices. Through the capabilities within CTMC and our alliance with MD Anderson Cancer Center and National Resilience, we co-develop cell therapy products with biotech companies and help them industrialize and accelerate their innovative therapeutics to reach the clinic quicker and ultimately maximize patient impact.

CTMC is housed in a state-of-the-art 60,000sqft development and manufacturing facility in the Texas Medical Center with an integrated team of 75 industry veterans and scientists with a depth of cell therapy expertise. The unique structure of our joint venture with two highly established partners gives the organization financial stability and a long-term horizon, despite the current environment of funding uncertainty in the biotech field. Our broad scope and novel corporate structure allow employees a plethora of development opportunities for members of our team. We are passionate about aggressively bringing life-saving cures to patients and achieving it through a cohesive team-first culture and balanced work-life environment for our staff. If you feel you can contribute to our mission and be part of a newly imagined biotech, we welcome your application.

Responsibilities

• Work specifically on the development of product characterization assays and help establish correlations between clinical outcomes and product/process characteristics of ex vivo T-cell therapeutics.
• Develop, optimize, and pre-qualify (if needed) analytical methods in various platforms including, flow cytometry, ELISA, qPCR and/or ddPCR.
• Work closely with process development, apply developed methods to inform in-process characterization (phenotypic and functional) of gene edited cells.
• Collect and interpret data, prepare development reports, and present results to cross functional project team to provide updates on project status/ progress.
• Support the development of standard operating procedures, test methods and associated forms, batch records, analytical descriptions, and sampling plans.
• Adhere to organizational safety, environmental and industrial hygiene procedures, and practices, and actively participate in maintaining and enhancing the safety of the workplace and the laboratories.
• Apply organizational and creative skills to improve lab operations and workflow efficiencies.
• Other duties as required.

Qualifications/Skills

• Ph.D. in a related scientific/engineering field preferred or Masters degree with 6 years’ experience in a relevant field.
• Previous experience in Analytical Development or Quality Control, particularly as related to T cell therapies.
• Demonstrated hands-on experience on the development flow cytometry assays - Designing multiparameter flow assays (5-10 colors) antibody/fluorochrome selection, optimizing staining protocols, developing compensation and gating strategies, method controls, etc. required.
• Previous experience operating and demonstrate technical knowledge of BD flow cytometers or equivalent
• Previous experience performing analysis of multiparametric flow data using software such as FlowJo, FCS Express, or others.
• Previous experience in developing other analytical methods for cell therapy products, e.g., cell-based functional assays, q-PCR/ddPCR assays, is a plus.
• Strong scientific understanding of the fundamental principles of immuno-oncology.
• 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.

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
• 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.