Associate Director, CMC Project Management

Vir Biotechnology

San Francisco (CA)

Hybrid

USD 163,000 - 228,000

Full time

3 days ago
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Benefits offered by this job

Health and welfare benefit plans
401K match
Lunch each day in the office
Company shutdown for holidays

Job summary

Vir Biotechnology is seeking an Associate Director of CMC Project Management to lead cross-functional CMC programs from early development through regulatory filings. You will manage integrated project plans, coordinate with external partners, and drive risk mitigation and schedule optimization to accelerate timelines.

This hybrid role is based in San Francisco with three onsite days. Ideal candidates hold a BS/MS in a biotech-related field, 10+ years in CMC/biotech functions, and at least 5

Qualifications

  • 10+ years in CMC Development, CMC Regulatory Affairs, Quality, Technical Operations, or related biotech/pharma functions.
  • Minimum 5 years of project or program management experience in drug development.
  • Strong understanding of cGMP and quality management systems.

Responsibilities

  • Lead cross-functional CMC development programs from early-stage to late-stage development and regulatory filings.
  • Coordinate external partners, CMOs, and vendors within integrated project plans.
  • Drive risk identification, mitigation strategies, and scenario planning to support timelines.

Skills

Cross-functional leadership
Communication
Project management
Risk management

Education

BS or MS in Biotechnology/related field

Tools

PMP

Job description

Associate Director, CMC Project Management

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.

  • compensation, bonus and 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

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 .

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Vir Biotechnology’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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