Senior Manager, Biomanufacturing

Senior Manager, Biomanufacturing

Our client is an industry-leading public biotech company with several FDA-approved therapies on the market! They’re well funded and constantly expanding an already diverse pipeline.

 

HireMinds is helping them find an experienced Senior Manager to lead the cell production efforts. If this sounds exciting to you, apply today!

 

Responsibilities:

  • Effectively manage team of bioprocess and manufacturing technicians
  • Serve as SME on all bioprocess and manufacturing operations (covers cell isolation, sorting, culture, expansion, analysis)
  • Ensure quality documentations are completed in a timely manner, performing investigations and CAPAs as necessary
  • Build, maintain, and motivate team to ensure achievement of all productivity targets and output requirements; Develop and implement objectives for the team; Onboard and train new employees in documentation and process execution; Set expectations for employees, conduct regular performance reviews, mentor, coach,
  • Review team master batch records, documentation, and data entry
  • Monitor and report progress of manufacturing operations projects against timelines
  • Ensure that the team meets all compliance, OSHA, and GMP requirements
  • Implement process improvements designed to gain efficiencies and increase compliance and safety
  • Review and edit experimental plans, SOPs, and MBRs; submit SOPs and MBRs in compliance with Quality standards
  • Communicate cross-functionally with other departments to ensure alignment of goals
  • Work with operations and procurement to track and maintain inventory/resources, equipment, and team expenditures
  • Manage scheduling, process monitoring, and compilation of donor information
  • Ensure the manufacturing area adheres to site requirements for compliance and safety

 

Qualifications:

  • B.S. in bioengineering, cell biology, or related discipline with
  • 10+ years of industry experience in a GMP cell production environment
  • 2+ years of experience managing and leading teams
  • Expertise in human cell line culture and scale-up
  • Expertise in primary cell isolation and culture
  • Knowledge of good documentation and GMP