Senior Manager, CMC Program Management

Redwood City, California
Mar 24, 2018
Required Education
Position Type
Full time

ARMO BioSciences is looking for a Senior Manager / Associate Director CMC Program Management. This position will be providing CMC program management to ensure that all requirements are met per the agreed upon timelines and budgets. Manage working relationships with multiple Contract Development and Manufacturing Organizations (CDMO). Ensure effective cross-functional communications within the ARMO CMC team and with and between CDMOs.

Responsibilities and Job Functions

  • Facilitate CMC program planning and execution; serves as the primary point of contact for API CDMO communications
  • Facilitate tech transfer to commercial scale CMOs
  • Track progress and payments for API CDMOs
  • Facilitate setting program objectives, milestones and scope
  • Schedule and coordinate team meetings, prepare and/or coordinate pre-meeting materials, issue timely agendas/minutes.
  • Work with Tech Ops / CMC teams to identify key risks, timeline and resource issues, and develop mitigation plans
  • Work with Quality to ensure appropriate CMC documentation is in place
  • Collaborate with the CMC team to build annual budgets
  • Anticipate project challenges and risks and prepares proactive mitigation strategies
  • Other duties as assigned

Knowledge, Experience and Skills

  • Reports to Head of Program and Alliance Management; Level is flexible depending upon experience
  • Bachelor’s degree in chemistry or a biological science required; higher degrees are desirable
  • Project Management Professional (PMP) certification desired
  • 5+ years of industry experience with a minimum of 3 years of hands on experience in biologics CMC program management
  • Prior global and commercial experience desired
  • Direct experience developing and managing timelines and budgets from development through commercial launch
  • Must work well in teams and have demonstrated ability to function independently and be self-motivated
  • Must be proficient with MS Project and other project management tools
  • Approximately 10 - 20% travel required