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Manufacturing Lead - Downstream

Indianapolis $34 - $36 p/h Contract

Job Responsibilities:

  • Lead the execution of downstream manufacturing activities such as clarification, chromatography, TFF, and filling, working collaboratively within a team.
  • Serve as a liaison with downstream process development subject matter experts (SMEs) to stay updated on the latest processes and ensure seamless translation of these to the GMP manufacturing environment.
  • Manage material supplies to ensure downstream manufacturing areas are stocked and ready for operations.
  • Assist with the maintenance of laboratory equipment and support overall lab operations.
  • Lead the creation, review, and revision of SOPs, batch records, and forms in collaboration with management, Process Development, and Quality Assurance teams.
  • Provide clear direction to operators on downstream manufacturing processes and assist with training and coaching as needed.
  • Accurately follow detailed instructions and ensure timely, precise documentation of all manufacturing activities.
  • Maintain current training status and ensure compliance with all relevant policies and SOPs.
  • Lead troubleshooting efforts for downstream manufacturing issues, working with Manufacturing Management when necessary.
  • Train new team members and colleagues on downstream manufacturing processes.
  • Conduct safety inspections and maintain a safe work environment.
  • Perform sanitization of manufacturing areas and properly collect/dispose of waste.
  • Collect process data for trending and metrics.
  • Support GMP product optimization and improvements.
  • Assist in specification development, review, and implementation through CAPAs and change controls.

Qualifications:

  • Bachelor’s degree in Biology, Biochemistry, Molecular Biology, or a related field.
  • 2 years of experience in a GMP environment.
  • 2 years of experience operating in a GMP laboratory using aseptic techniques and risk mitigation strategies.
  • Experience with chromatography and TFF platforms.
  • Experience in cell and gene therapy manufacturing or viral vectors is desired.


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