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Director of Operations

Company: Management Recruiters International, Inc.
Location: Irving
Posted on: February 25, 2021

Job Description:

Siter-Neubauer & Associates is currently conducting a search for Director of Operations: My Client is a major player in the bio-therapeutic market space. Their products are selling well. The pipeline is full. They are in a growth mode. Job Description They are seeking to fill a
very important position-the Director of Operations. The successful candidate
will be responsible for not only overseeing the construction of a clean room
facility but also the development of the biologic/cellular therapy product with
a unique delivery system. This will entail the scale up and tech transfer of
biologic products into manufacturing. Qualifications

  • Provide leadership to cross-functional teams to perform technology transfers, process validation, scale-up and optimization activities.
  • Experience in working as part of a cross-departmental team and successfully integrating with R&D, Clinical, Regulatory, Manufacturing and Quality groups.
  • Requires strong project management experience and process improvement experience, with at least 10 years relevant experience leading technical services/operations, process development, and/or engineering support activities.
  • A working knowledge of regulatory pathways employed for product development and changes to approved products.
  • Knowledge of regulations and guidance such as cGMP, QSRs, SUPAC, and ICH is required to allow oversight of the variety of projects tasked to this position.
  • Lean/Six Sigma Green Belt certification and experience considered an advantage
  • Must have technical expertise in various cell culture methods to oversee the scale up, tech transfer and large scale production of biologic products.
  • In-depth knowledge of a compliance with cGMP requirements, ISO environments, and FDA regulations for a sterile, Class A manufacturing environment.
  • Technical expertise in cell culture, virology, fermentation, and protein purification with a 4 year degree in Biology, Immunology, Biochemistry, or similar.
  • Implementation of Six Sigma, Kaizen, PDSA, and other CIPs.

Keywords: Management Recruiters International, Inc., Irving , Director of Operations, Executive , Irving, Texas

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