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Scientist, Cell Therapy Drug Product Development - CTMC

Company: BioHouston
Location: Houston
Posted on: September 17, 2023

Job Description:

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned 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, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson's research and clinical faculty, bringing impactful cell therapies to cancer patients.In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and 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 mission.At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. 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

  • Develop robust processes of formulation, fill and finish, and cryopreservation for chimeric antigen receptor T (CAR T) and Tumor-Infiltrating Lymphocytes (TIL) cell products.
  • Design and execute studies on formulation, fill/finish, and cryopreservation of candidate cell therapy product.
  • Evaluate new cryobiological technologies. -
  • Implement process advancements for scaling-up and introduction into a GMP manufacturing environment.
  • Lead technology transfer activities and training manufacturing staff on new processes and equipment,
  • Monitor process performance during clinical manufacturing via data tracking, trending, and analysis.
  • Design and conduct experiments in development laboratory to support process changes, generate process robustness data, and/or resolve manufacturing non-conformances.
  • Draft technical documents including development reports, process descriptions, risk assessments, SOPs, MBRs, and regulatory filing sections.
  • Act as internal expert and maintain state-of-the-art knowledge in the field of cellular cryopreservation and cryobiology.
  • Other duties as assigned.Qualifications/Skills
    • Ph.D. in a related scientific/engineering field preferred, or Master's degree with 5+ years' experience in a related field, preferably in the biotech industry or equivalent combination of education and experience.
    • Strong knowledge and hands-on experience with cell therapy process development and cryopreservation.Highly desired experience:
      • Formulation science experience with cryoprotectant additives.
      • Demonstrated aseptic cell handling skills.
      • Experience working in or supporting a cGMP-regulated environment.
      • Hands-on experience with common cell therapy laboratory equipment and technology platformsFamiliarity with the following is a plus:
        • Solid background in cell therapy manufacturing processes
        • Proficient with MS Office (Excel, Outlook, etc.) and statistical software (Prism, JMP).
        • Strong scientific understanding of the fundamental principles of cryopreservation and cell therapy.
        • 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 a lab and 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 equipmentPhysical 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. -

Keywords: BioHouston, Houston , Scientist, Cell Therapy Drug Product Development - CTMC, Healthcare , Houston, Texas

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