Manager, Manufacturing (cGMP Cell Therapy)

Manager, Manufacturing (cGMP Cell Therapy)

  HireMinds is seeking a Manufacturing manager to oversee cGMP manufacture of cell therapy products. In this role you will responsible for a team that will execute cGMP manufacturing and cell culture for autologous and allogenic cell therapies. You will work building manufacturing operations under cGMP in a state-of-the-art facility with an amazing team of experts in the cell therapy space. If you are seeking to lead a manufacturing team and have an expertise in cGMP cell therapy products reach out to the HireMinds Biotech team today to learn more.

In This Role You Will:

  • Bring a technical expertise in the cGMP manufacturing and aseptic processing
  • Establish manufacturing and operational plans for cGMP cell therapy including the duties of equipment selection, developing Standard Operating Procedures (SOPs), batch record capture, risk assessments procedures and protocols, material order and supply operations
  • Provide daily management and reporting on manufacturing operations and supply chain delivery including offering improvements and quality standards with teams
  • Recruit and establish a manufacturing team including oversight with key performance standards of the organizational goals
  • Identify any key risks and issues to manufacturing and mitigate with improvements once agreed upon with site leadership team.
  • Guide production staff in troubleshooting process and equipment problems as they arise
  • Technical expertise with primary cell culture and associated technologies and equipment including: CliniMACS, CliniMACS Prodigy, LOVO, WAVE bioreactors Xuri or G-Rex system
  • Ability to collaborate with teammates in Regulatory, Quality Assurance, Quality Control, and Process Development in resolving issues like deviations, CAPAs, Change Controls
  • Review completed batch records to ensure accuracy with an eye for quality
  • Build, develop, and execute new training programs including materials and tutorials which will close training gaps and support ongoing staff’s continued learning in seeking operational excellence

In This Role You Are Required To Have:

  • BS/MS degree in manufacturing related field with 5-10 years of experience in cGMP manufacturing in Biopharma industry setting
  • 5+ years of direct cell therapy manufacturing experience (CAR-T, TCR, NK cell therapy products)
  • 5+ years of manufacturing team leadership success
  • Experience with Manufacturing Engineering Systems (MES) and integrated automation in manufacturing setting
  • Effective communication and collaborative work style to adapt with a novel and diverse portfolio of cell therapy and immunotherapy products and programs
  • Biotech work ethic with ability to problem solve and troubleshoot on the fly while working within proper quality and regulated standards