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    TSMS Scientist - Charlottetown, Canada - Elanco

    Elanco
    Elanco Charlottetown, Canada

    1 week ago

    Default job background
    Full time
    Description

    Responsibilities:

  • Serve as a process capability specialist utilizing statistical modeling to advance site capabilities.
  • Participate in site investigations; enhancing the site technical knowledge; understanding and problem solving.
  • Participate in the manufacturability review process and Process Quality Review.
  • Partner with R&D to enable commercialization of new products and R&D to execute scale up, registration and validation activities.
  • Ensure that the right control strategies are in place.
  • Conceive of and lead continuous improvement initiatives through Life Cycle Management.
  • Minimum Qualifications (education, experience and/or training, required certifications):

  • Master's degree in bioengineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology, or equivalent scientific degree and experience.
  • Experience with a variety of technologies and including vaccine technologies, recombinant protein platform, protein-based, purification, fermentation technology, lyophilization and sterile filling technology.
  • Experience in problem solving and tools available.
  • Experience in statistical analysis.
  • Ability to influence people.
  • Ability to build collaborative relationship with areas inside and outside Elanco, to build the network.
  • Familiarity with global Regulatory Standards (EU GMP, USDA, CFIA).
  • Experience in lean approach/principles.
  • Additional Preferences:

  • Master's degree with 3-5years' experience
  • Experience in project management, PMP certification.
  • Experience with SAP, JMP, Veeva Vault.
  • Experience Leading technical transfer operations specifically:Serving as a subject matter expert (SME) for site specific projects.Ensuring that the transfers are in accordance with the cGMP and respond to the requirements for the dossier submission.Driving the execution of tech transfer to ensure that they are accomplished on time, with robust manufacturing control strategies implemented PEI's site.
  • The salary range for this position is $80,000 to $120,000 which will be determined based on relevant experience and education.

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