Manufacturing Team Lead

3 weeks ago


Indianapolis, United States Harba Solutions Inc. Full time

Responsibilities:

  • Leading manufacturing activities in a team setting, focusing on clarification, chromatography, and filling processes.
  • Ensuring that manufacturing areas are properly stocked and prepared.
  • Assisting with the maintenance of laboratory equipment and supporting laboratory operations.
  • Creating, reviewing, and updating standard operating procedures (SOPs), batch records, and relevant documentation in collaboration with management, process development, and quality assurance teams.
  • Clarifying roles and responsibilities for downstream processes and providing coaching and training to operators as needed.
  • Maintaining a high level of attention to detail while following instructions and completing documentation promptly.
  • Keeping training status current and maintaining clean laboratory spaces and equipment.
  • Troubleshooting manufacturing issues with guidance from management and training new staff on downstream processes.
  • Adhering to safety protocols and performing safety inspections.
  • Using industrial equipment for operational tasks and ensuring compliance with waste disposal procedures.
  • Contributing to data collection for process metrics and supporting the optimization of GMP products.
  • Collaborating with process development, quality assurance, and other departments as necessary.


Qualifications:

  • Bachelor's degree in Biology, Biochemistry, Molecular Biology, or a related field
  • 2+ years experience in a GMP environment
  • Minimum of 2 years working in a GMP laboratory, employing aseptic techniques and risk mitigation strategies


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