CMC Project Manager

Leap Therapeutics is seeking a motivated self-starter with CMC project management experience with biologics manufacturing 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 play a key role in the project management and integration of cross functional CMC activities to support clinical and commercial development of monoclonal antibody therapies.

They will collaborate with various internal and external functions including downstream manufacturing, quality control, quality assurance, regulatory, and supply chain to ensure that plans and schedules support business priorities.

Specific responsibilities include:

  • Develop and maintain project schedules for CMC operations including process development, manufacturing, quality, and supply chain 

  • Assist the functional area leaders with driving decision making for the project

  • Support preparation and management of CMC program budget(s)

  • Maintain agendas, meeting minutes, action items, dashboards, risk register, mitigation plan, decision logs, etc.

  • Assist with identifying and defining risks, mitigations, and/or contingency plans.

  • Execute scenario planning and provide options for teams

  • Ensure project progress and upcoming deliverables are understood by the CMC team and ensure that action items are tracked to completion

  • Support management of strategic external relationships by aligning internal and external requirements/resources to achieve timelines, milestones, and deliverables.

  • Assist with the creation and update of near- and long-term project plans with clearly defined goals

  • Report program status into governance meetings



Education / Experience / Skills:

  • Minimum of B.S. in biology, bioengineering, biochemistry, or equivalent

  • Minimum of 5-10 years experience; preferably hands-on in a relevant CMC area of biologics (for example, cell culture, purification, or fill/finish) followed by strong project management experience  

  • Advanced understanding of project management tools

  • 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

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