Director / Associate Director, Process Development

Director / Associate Director, Process Development

Bay Area, California

 

  HireMinds is helping a growing biotech in the San Francisco Bay Area build out their Process Development team! You'll have the chance to manage and build a team within a company that is discovering and developing clinically relevant allogeneic cell therapies for the treatment of cancer and other diseases. If you are excited to join a growing and intimate team (~90 employees) locally and work in a cross-functional capacity this is a great role to consider. We are seeking a true leader who is passionate about coaching, building, and elevating a talented team of process development engineers.

 

Responsibilities:

  • Lead a process development group for the development of CAR T products based on the T cell platform
  • Design studies utilizing novel technologies to improve platform processes prior to transition to MS&T team
  • Create improvements to platform process for activation, transduction, and expansion unit operations
  • Lead studies to identify and characterize individual donor attributes which impact final product CQAs
  • Supervise the execution of CMC studies on candidate products, present data, and advise on suitability to move forward through development pipeline for IND filing and cGMP manufacturing
  • Authorship of development reports for use in CMC regulatory filings
  • Ensure complete and accurate data entry for process development team members including review and approval of electronic notebook entries and aggregate data files
  • Collaborate with research, molecular biology, viral vector, and immunology teams to identify potential concerns and bottlenecks for product development
  • Ensure timely onboarding of personnel and provide oversight for onboarding and training of new scientists and research associates/engineers

 

Qualifications:

  • PhD in life sciences or biotech engineering
  • 6+ years of industry experience and 3+ years of people management experience
  • Experienced with tools and equipment to enable cGMP manufacturing as well as limitations in order to enable implementation of process improvements for the manufacturing of allogeneic cell therapy products
  • Familiar with T cell flow cytometry assays and other cell-based characterization assays (e.g. Nanostring, Cytoflow, RNAseq, single-cell analysis)
  • Strong leadership skills & the ability to communicate and partner well with all levels of staff
  • Proven ability to troubleshoot and resolve issues

 

Contact tricia@hireminds.com to apply and interview soon.