Associate Director, CMC Project Management

Posted 4 Days Ago
Be an Early Applicant
San Francisco, CA, USA
Hybrid
163K-228K Annually
Expert/Leader
Biotech
The Role
Leads cross-functional CMC development programs from early development through regulatory filing and commercial lifecycle management. Responsibilities include integrated project planning, vendor and CMO coordination, risk mitigation, critical-path analysis, portfolio reporting, budgeting, resource forecasting, process improvement, and operational excellence across CMC functions.
Summary Generated by Built In

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.


WHAT YOU'LL DO

  • 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

WHO YOU ARE AND WHAT YOU BRING

  • 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

WHO WE ARE AND WHAT WE OFFER

 

The expected Salary range for this position is $162,500 to $227,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.

Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person’s experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.

Applicants must currently be authorized to work for any employer in the U.S.  We are unable to sponsor or take over sponsorship of an employment Visa at this time.

All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics. 

This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.  Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.

Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes. We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.

For hires based in the United States, Vir Biotechnology, participates in E-Verify.

Candidate Privacy Notice

 

Skills Required

  • 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
  • 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, navigate ambiguity, solve complex problems, and support decision-making
  • Experience working with external partners, CMOs, suppliers, strategic alliances, and remote or global teams
  • Advanced degree or certification such as PhD, MBA, PMP, or PMI
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The Company
HQ: San Francisco, CA
611 Employees
Year Founded: 2016

What We Do

Vir Biotechnology, Inc. (in Europe, Humabs BioMed, https://bit.ly/46lQGN2) is an immunology company focused on powering the immune system to address unmet patient needs in infectious disease and beyond. Our powerful R&D engine combines our proprietary monoclonal antibody (mAb) platform with machine learning and artificial intelligence-enhanced capabilities, enabling us to engineer our rich database of human antibodies and deliver transformative medicines for diseases with significant global burden. Our current pipeline consists of multiple clinical candidates targeting hepatitis B and hepatitis delta viruses and human immunodeficiency virus, including a potential functional cure for chronic hepatitis B and treatment for chronic hepatitis delta. Our portfolio of broad, potent investigational monoclonal antibodies also targets influenza A and B viruses, COVID-19, respiratory syncytial virus/human metapneumovirus and human papillomavirus, and our investigational T cell vaccine aims to prevent HIV. Explore our full pipeline: https://bit.ly/3tr7FPm We collaborate with some of the world’s leaders in industry as well as government agencies and non-profit organizations enabling us to rapidly advance cutting-edge scientific discoveries and innovative technologies with the potential to benefit people around the world. We are proud to have been ranked the fastest-growing company in North America on the 2022 Deloitte Technology Fast 500™. Join us as we pursue our mission to transform lives. It has come to our attention that there have been various recruitment scams targeting job seekers on LinkedIn. Vir Biotechnology, Inc. is committed to your privacy and will never request sensitive personal information including banking details through email, text message, social media or video software platforms. We also will never request a financial commitment from a candidate as part of the application process. Learn more about Vir’s recruiting process: https://bit.ly/461EgJN

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