Manager/Sr. Manager, CMC Downstream Development and Manufacturing

Leap Therapeutics is seeking a motivated individual with biological downstream process development experience to be part of a growing oncology company. S/he will join the Biological CMC Development and Manufacturing team as a Downstream Manager or Senior Manager.
The role is within a highly collaborative team environment. S/he will assist in developing and implementing operational plans to meet project timelines and the company’s business objectives.

General Responsibilities
The successful candidate will assist in managing external drug substance and drug product development and external manufacturing sites. S/he will collaborate with various internal and external functions including process development, analytical, quality, regulatory, and clinical.

Specific responsibilities include:

  • Assist in the development of robust purification processes utilizing multiple chromatography modes, filtration, and clarification technologies at CDMO site.

  • In collaboration with CDMO design, optimize, and characterize downstream manufacturing

  •  Ensure well-organized, clear and complete documentation of all activities across all areas of
    process based upon quality by design (QbD) principles.

  •  Assist in liquid drug product formulation development, technical transfer and fill at CDMO site.

  •  Assist with the technical transfer, scale-up and manufacturing of biological drug substance and 
    drug product to support late-stage clinical studies.

  •  Interface with upstream, analytical, formulation, regulatory, QA/QC groups to ensure alignment 
      with overall program objectives.

  • Participate in designing phase appropriate viral clearance studies to enable regulatory 

  • Prepare supporting documents for CMC sections of regulatory submissions.

  • Establish and maintain an understanding of current trends in purification technologies

  • Set clearly defined goals/objectives with contract organizations to ensure delivery of high-
    quality results while maintaining timeline and budget.


Education / Experience / Skills:

  • BS or MS in chemical engineering, biochemistry, or closely related field.

  • 6 – 10 years of relevant experience within a process development and/or technical transfer 

  • Must have hands on experience with chromatography and membrane biological process development and 
    scale up.

  • Experience with external contract partners is desired but not required.

  • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.