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Process Development

Organizational Relationships:

  • The Development Technologist will report to the Director of Manufacturing and Process Development and work under the guidance of the Senior Development Technologist.
  • The Development Technologist will collaborate closely with Research & Development, Manufacturing, Quality Control and Quality Assurance associates for daily execution of process development responsibilities.
    Position overview
  • Work as part of a multidisciplinary project team to develop innovative technology and process improvements to the product manufacturing process. Evaluate new techniques and technologies and participate in the assessment of the Company's technology platform to new disease indications.
  • Demonstrate ability to identify issues, offer alternatives, and implement newly recognized courses of action as determined by the team.
  • Implement and maintain procedures to ensure compliance with company quality systems, safety systems and technical excellence. Maintain comprehensive records of all work and write and review formal reports. Generate and maintain necessary batch records, SOPs, EOPs and process control forms in accordance with company policies.
  • Perform the technical transfer of knowledge, procedures, process improvements and techniques to manufacturing personnel and other appropriate departments.

Minimum Education and/or Experience Required:

  • Bachelor's Degree in medical technology, blood banking or other relevant scientific discipline.
  • Demonstrated ability to work collaboratively as a member of a project team and to communicate effectively with colleagues
  • Strong working knowledge of GTP, GMP, and GLP guidelines, including direct experience in GMP manufacturing and/or process improvement in the Biotech/Pharmaceutical industries
  • Working knowledge of the scientific and technical aspects of T-cell culture is desirable.
  • Demonstrated knowledge and application of pertinent or comparable computer programs, as well as working knowledge of MS Office programs (e.g. Excel, Word).

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