Virbiotechnologyinc

Associate Director, CMC Project Management

San Francisco, California, United States. Posted a month ago

The role

This person will lead and coordinate cross-functional CMC activities for early-stage development programs. They will partner with technical and functional teams to ensure program execution and drive continuous improvement initiatives.

What you will do

  • Lead cross-functional CMC development programs from early-stage through late-stage, technology transfer, regulatory filings, and commercial lifecycle management
  • Develop and execute integrated project plans including coordination of external partners, vendors, suppliers, and CMOs
  • Drive scenario planning, risk identification, and mitigation strategies
  • Facilitate effective communication across CMC functions
  • Perform critical path analyses to accelerate timelines and reduce program risk
  • Standardize project reporting and portfolio management processes
  • Partner with CMC leadership to implement new tools, systems, and business processes
  • Support annual planning and budgeting activities, including resource forecasting and operational planning
  • Contribute to operational excellence initiatives and continuous improvement efforts

Required qualifications

  • BS or MS in Biotechnology, Chemical Engineering, Biology, Chemistry, or a related scientific discipline
  • 10+ years of experience in CMC Development, CMC Regulatory Affairs, Quality, Technical Operations, or related biotechnology/pharmaceutical functions
  • At least 5 years of project or program management experience supporting drug development programs
  • Proven experience leading complex, cross-functional CMC programs and managing timelines, budgets, resources, and priorities
  • Strong understanding of CMC development activities, cGMP requirements, and quality management systems
  • Excellent communication, meeting facilitation, and presentation skills
  • Ability to manage multiple programs simultaneously, navigate ambiguity, and solve complex problems

Nice to have

  • PhD, MBA, PMP, or PMI
  • Experience working with external partners, CMOs, suppliers, strategic alliances, and remote or global teams

Benefits

  • compensation
  • bonus
  • equity
  • health and welfare benefit plans
  • non-accrual paid time off
  • company shut down for holidays
  • commuter benefits
  • 401K match
  • lunch each day in the office

Before you apply

  • Applicants must currently be authorized to work for any employer in the U.S.
  • Unable to sponsor or take over sponsorship of an employment Visa at this time
  • Vir Biotechnology participates in E-Verify

About the company

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing medicines for serious infectious diseases and cancer.

Associate Director, CMC Project Management at Virbiotechnologyinc | JobZoey