Manager, CMC Project Management

Loyal
Full-time
Remote
$112,000 - $168,000
Posted on 5 months ago

Job Description

Loyal is seeking an experienced Manager of CMC Project Management to support the development of FDA-approved longevity therapeutics, focusing on advancing drug substance and drug product programs from development through registration.

Responsibilities

  • Lead and facilitate cross-functional CMC project teams
  • Serve as a key liaison between CMC, Program Management, and stakeholders
  • Act as the primary point of contact for project status and risk resolution
  • Develop and monitor project plans and timelines
  • Manage multiple CMC projects to ensure milestones are met
  • Support and represent CMC functions in project teams
  • Proactively identify and escalate risks
  • Partner with CMC leadership to drive resolution
  • Ensure accurate budgeting and financial tracking
  • Contribute to long-range planning and resourcing
  • Coordinate with CDMOs and external vendors
  • Monitor performance and alignment with project goals
  • Create and deliver dashboards and updates
  • Document and track meeting agendas and action items

Requirements

  • Bachelor’s degree in biological sciences or related field
  • Minimum of 8 years’ experience in the pharmaceutical industry
  • Proven experience with drug substance and drug product development
  • Deep understanding of CMC processes and regulatory expectations
  • Strong grasp of project management methodologies and tools
  • Exceptional organizational, problem-solving, and risk-management skills
  • Excellent written and verbal communication skills
  • Demonstrated ability to think critically and develop solutions
  • Commitment to quality and ethical conduct

Benefits

  • No benefits