Associate Director, CMC Project Management (Temporary)

Vir Biotechnology
San Francisco, CA
On-site

Who this role is best for

Strong fit for experienced CMC project managers who lead cross-functional teams and manage timelines, budgets, and regulatory processes.

Best fit for

  • Experienced CMC professionals with a track record of managing complex drug development programs
    — “Proven experience leading complex, cross-functional CMC programs”
  • Candidates who excel in aligning teams and managing evolving priorities in biopharma
    — “Excellent communication, meeting facilitation, and presentation skills”
  • Individuals with a background in CMC development and regulatory affairs
    — “10+ years of experience in CMC Development, CMC Regulatory Affairs”

Things to consider

  • This role requires in-office presence three days per week in San Francisco
    — “with the expectation to be onsite three days per week”
  • No visa sponsorship is available for this temporary position
    — “We are unable to sponsor or take over sponsorship of an employment Visa”

How to stand out

  • Highlight experience with technology transfer and regulatory filings in your resume
    — “Lead cross-functional CMC development programs ... through late-stage development, technology transfer, regulatory filings”
  • Emphasize your ability to standardize processes and improve CMC efficiency
    — “Partner with CMC leadership to implement new tools ... improve efficiency and effectiveness”
  • Showcase your experience managing global teams and external vendors
    — “Experience working with external partners, CMOs, suppliers, strategic alliances”
Pace · Fast PacedCollaboration · HighAutonomy · MediumDecision Impact · Team

Derived from job-description analysis by Serendipath's career intelligence engine.

What success looks like

  • cross-functional CMC program management
  • budgeting
  • operational planning
  • continuous improvement
Typical background
project managementCMC developmentregulatory affairs

Skills & requirements

Required

Cross-functional Project ManagementCMC DevelopmentRegulatory AffairsQuality ManagementSupply Chain ManagementBudgetingOperational PlanningContinuous Improvement

Preferred

PhdMBAPMPPMI

Stack & domain

Project ManagementCMCRegulatory AffairsQualityTechnical OperationsBudgetingToolsSystemsBusiness ProcessesLeadershipCommunicationProblem-solvingTeamworkStrategic ThinkingPMPPMIPharmaceuticalsBiotechnologyQuality Management

About the role

Original posting from Vir Biotechnology via Greenhouse

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 Temporary Project Manager to support the coordination and execution of cross-functional CMC activities for early-stage development programs. This temporary staff member will partner closely with teams across Process Development, Analytical Development, Quality, Regulatory, and Supply Chain to help drive program goals and key deliverables.

The role will also support continuous improvement initiatives across CMC business processes, portfolio management, operational excellence, and budgeting activities. This position reports to the Vice President of CMC Strategy and Operations.

This is a temporary staff position 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 hourly rate for this position is $78.00 to $109.00 per hour. 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.

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Source: Vir Biotechnology careers (Greenhouse)

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