Biologics Manufacturing Technology Lead

3 weeks ago


Bismarck, North Dakota, United States Kelly Science, Engineering, Technology & Telecom Full time

At Kelly Science, Engineering, Technology & Telecom, we are seeking a skilled Biologics Manufacturing Technology Lead to join our team.

About the Role:

The primary responsibility of this position is to support the manufacturing team as a technology transfer leader and technical advisor. The ideal candidate will have experience in MSAT and/or GMP production with >5 years of experience as a technical SME for manufacturing scale in similar roles.

Key Responsibilities:

  • Demonstrate a thorough understanding of current Good Manufacturing Practices and Quality standards.
  • Exhibit proficiency in understanding concepts and scale-up requirements for all departmental disciplines.
  • Transfer processes to manufacturing, adapting them to large-scale production with limited supervision.
  • Provide suggestions for process optimization and efficiency, where applicable.
  • Perform Facility Fit analysis and work in conjunction with the engineering group to source new production equipment.

Requirements:

  • An advanced degree (M.S. or Ph.D.) in Chemical Engineering or life sciences required with laboratory experience.
  • A minimum of 4 – 10 years of experience in MSAT and/or GMP production with >5 years of experience as a technical SME for manufacturing scale in similar roles.
  • Proven track record of supervising a group of 4+ employees in a biologics technical SME production environment.
  • Experience in early-phase, and late-phase technical transfer and scale-up required.
  • Experience authoring GMP documentation required.
  • Proficient verbal communication and presentation skills required to translate general scientific and manufacturing concepts to a broad audience.

Estimated Salary: $120,000 - $150,000 per year based on location and industry standards.



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