Sr. Director CMC Operations
Takeda Pharmaceuticals - Bozeman, MT

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OBJECTIVES:

  • To effectively direct the design and scale up of processes, instruments, and equipment from the laboratory through pilot plant and manufacturing scale up.

  • To effectively direct the development, implementation, and maintenance of process methods and equipment for the production of process formulas, technologies, and products to achieve cost effectiveness and improved product quality.

  • To plan and implement the development of new process formulas, establish operating equipment specifications, and improve manufacturing techniques and new process equipment production.


  • ACCOUNTABILITIES:

  • Responsible for the development, transfer, and validation, if required, of unit processes, including fermentation, recovery, and downstream purification for the company‚Äôs biologic drug substances, including but not limited to recombinant proteins and monoclonal antibodies.

  • Responsible for directing development of multiple assays for screening in-vitro and in-vivo biological targets.

  • Responsible for overseeing screening operations, including scheduling, assay performance, and data flow.

  • Responsible for overseeing collection and interpretation of data for biomarker and biological characterization assays, including cell-based, multiplexed protein assays, polymerase chain reaction, and flow cytometry methods.

  • Responsible for directing development of biochemical assays for lead validation and optimization for disease-related targets.

  • Responsible for acting as liaison with research and/or development personnel to ensure processes and designs are compatible.

  • Responsible for selecting, developing, and evaluating personnel to ensure the effective operation of the function.


  • Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
    • PhD in chemistry, biochemistry, or closely related field

    • Biologics and analytical development experience required; in vaccines preferred

    • Track record of success required, including effectively leading and managing multi-functional groups

    PHYSICAL DEMANDS:
    • Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).

    TRAVEL REQUIREMENTS:
    • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.

    • Requires approximately 20% travel.

    We are driven to improve people's lives.

    www.takedajobs.com

    We are an equal opportunity employer.

    No Phone Calls or Recruiters Please.

    Schedule
    Regular Full-time

    Takeda Pharmaceuticals - 15 months ago - save job - block
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