Associate Director/Director, Upstream Process Development and Manufacturing

Leap Therapeutics is seeking a motivated individual with substantial upstream process development and manufacturing experience with biologics to be part of a growing oncology company.

They will work within a highly collaborative team environment to assist in developing and implementing operational plans to meet project timelines and the company’s business objectives


General Responsibilities
The successful candidate will have responsibility for the technical oversight and management of outsourced upstream process activities including cell line generation, cell culture optimization, validation, and upstream GMP manufacturing of monoclonal antibodies at top tier external contract development and manufacturing organizations (CDMO).

They will collaborate with various internal functions including downstream manufacturing, quality control, quality assurance, regulatory, and supply chain to ensure best practices are implemented and followed at external contract manufacturing and testing labs, and internally at Leap.

Specific responsibilities include:

  • Manage all upstream process development, optimization, validation, and GMP manufacturing activities at top tier CDMOs for clinical supply through launch/BLA

  • Co-author batch records, validation protocols/reports in collaboration with the CDMO

  • Use creative problem-solving skills to independently troubleshoot experimental challenges - interpret data, define problems, establish facts, draw valid conclusions and make decisions

  • Assist with the trending of process development, validation, and manufacturing data for continuous process improvement

  • Manage drug supply/demand forecasting estimates

  • Manage operational budget and timelines

  • Participate in batch release with QA and QC including the review of batch records and supportive data

  • Provide technical input for the resolution of investigations, deviations, out-of-specification/out-of-trend, change control, and CAPAs at contract sites

  • Author relevant sections of IND/IMPD regulatory filings


Education / Experience / Skills:

  • B.S., M.S. or Ph.D. in cell biology, chemical engineering, bioengineering, biochemistry, or equivalent.

  • 10+ years (depending on education) of progressive hands-on experience in upstream process development and GMP manufacturing of monoclonal antibodies in the pharmaceutical/biotech industry

  • Substantial experience with managing external CDMOs

  • Process validation experience in support of late stage clinical programs preferred (DoE, IQ/OQ/PQ)

  • Experience with cell line development and cell banking

  • Advanced understanding of the application of FDA regulations and ICH guidelines from early development through commercial product

  • Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results

  • Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationships with cross functional personnel at all levels