Associate Director, CMC Project Management

Vir Biotechnology•San Francisco, CA

9d•$162,500 - $227,500•Hybrid

About The Position

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company. We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best. THE OPPORTUNITY Vir Biotechnology is seeking an experienced project manager to lead, coordinate, and drive cross-functional CMC activities supporting early-stage development programs. This individual will partner closely with technical and functional teams across Process Development, Analytical Development, Quality, Regulatory, and Supply Chain to ensure successful execution of program goals. In addition to supporting development programs, this role will help drive continuous improvement initiatives across CMC business processes, portfolio management, operational excellence, and budgeting activities. The position reports to the Vice President of CMC Strategy and Operations. This role is based in our San Francisco, California office with the expectation to be onsite three days per week.

Requirements

BS or MS in Biotechnology, Chemical Engineering, Biology, Chemistry, or a related scientific discipline; advanced degrees or certifications (PhD, MBA, PMP, PMI) are preferred
10+ years of experience in CMC Development, CMC Regulatory Affairs, Quality, Technical Operations, or related biotechnology/pharmaceutical functions, including 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 across multiple stakeholders and development stages
Strong understanding of CMC development activities, cGMP requirements, and quality management systems, with the ability to identify risks, develop mitigation strategies, and drive program execution
Excellent communication, meeting facilitation, and presentation skills, with the ability to influence across teams and drive alignment in a fast-paced, evolving environment
Demonstrated ability to manage multiple programs simultaneously, navigate ambiguity, solve complex problems, and support informed decision-making
Experience working with external partners, CMOs, suppliers, strategic alliances, and remote or global teams is preferred

Responsibilities

Lead cross-functional CMC development programs from early-stage development through late-stage development, technology transfer, regulatory filings, and commercial lifecycle management
Develop and execute integrated project plans aligned with overall program strategy, including coordination of external partners, vendors, suppliers, and CMOs
Drive scenario planning, risk identification, and mitigation strategies to support program execution and decision-making
Facilitate effective communication across CMC functions to ensure alignment on priorities, timelines, risks, resources, and strategic changes
Perform critical path analyses and proactively identify opportunities to accelerate timelines and reduce program risk
Standardize project reporting and portfolio management processes across supported CMC teams
Partner with CMC leadership to implement new tools, systems, and business processes that improve efficiency and effectiveness across the organization
Support annual planning and budgeting activities, including resource forecasting and operational planning to achieve departmental and program objectives
Contribute to operational excellence initiatives and continuous improvement efforts across the broader CMC organization