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.