About CTMC
Cell Therapy Manufacturing Center (CTMC), a joint venture between National Resilience Inc. and MD Anderson Cancer Center, is a first of its kind biotech located in the world-renowned Texas Medical Center. This unique venture brings together world-class academic cancer research, state-of-the-art cell therapy manufacturing technology platforms, and leaders in clinical cancer care to enable rapid advancement of novel therapeutics from concept to clinic and thereby increase patient access to life saving medicines.
CTMC aims to eliminate the bottlenecks that have hampered cell therapy advancement with a multidisciplinary team of dedicated researchers, physicians, drug developers and scientific experts who work collaboratively to develop novel first-in-class therapeutics in an industrial manner within the innovative environment of an academic cancer center. We work in a fast-paced, milestone-driven environment with a focus on team science and interdisciplinary research. Our unique business model has created a biotech-like engine within the walls of the nation's leading cancer center to bring life-saving medicines to our patients more quickly and effectively.
Responsibilities
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Works 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.
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Identify key metrics to help further characterize therapeutic products and identify potential Critical Quality Attributes (CQAs).
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Develop, optimize, and pre-qualify (if needed) analytical methods in various platforms including, flow cytometry, ELISA, qPCR and/or ddPCR.
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Work closely with process development, apply developed methods to inform in-process characterization (phenotypic and functional) of gene edited cells.
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Collect and interpret data, prepare development reports, and present results to cross functional project team to provide updates on project status/ progress.
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Support the development of standard operating procedures, test methods and associated forms, batch records, analytical descriptions and sampling plans. Act as subject matter expert in the training and transfer of analytical test methods to internal and external collaborators.
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Act as SME in the training and transfer of analytical test methods to internal and external collaborators.
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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.
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Apply organizational and creative skills to improve lab operations and workflow efficiencies.
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Other duties as required.
Qualifications/Skills
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Bachelor’s degree in a related field required, Ph.D. in a related scientific/engineering field preferred.
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10 yr.’s of relevant experience in biotech or contract testing organization; or combination of education and experience.
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Experience in Analytical Development or Quality Control, particularly as related to T cell therapies.
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Understanding of the FDA Regulatory requirements as related to cellular identity, purity, and potency.
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Required: Expertise and hands-on experience in the development of multi-parameter flow cytometry assays for the characterization of cell therapy products.
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Experience in developing other analytical methods for cell therapy products, e.g., cell-based functional assays, q-PCR/ddPCR assays, is a plus.
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Strong scientific understanding of the fundamental principles of immuno-oncology.
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Based on scientific understanding of the process, applies GMP requirements to analytical method development, clinical manufacturing, and process/assay transfer activities.
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Demonstrated ability to collaborate effectively in a multi-disciplinary team.
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Demonstrated strong communication skills, interpersonal skills, and a superior drive for results.
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Excellent written, oral, interpersonal and presentation skills and the ability to effectively interface with senior management and staff.
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Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills.
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Ability to operate as an effective tactical, as well as strategic thinker.
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Ability to coach and influence junior level scientists and associates.
Working Conditions, Equipment, Physical Demands
Equipment-
Computer, printer, fax, telephone, and laboratory testing equipment
Physical Demands-
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Occasional standing, walking required
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Frequent sitting, reaching, and computer/keyboard usage
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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.