Vir Biotechnology 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 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.
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.
We are looking for an Associate Director, External Operations professional where you will serve as a a member of the External Operations Leadership Team and support the delivery of the company’s clinical manufacturing and commercialization activities across Vir Bio’s portfolio. You will act as site lead accountable for the overall product delivery from our global external CDMO network. You will work in collaboration with internal stakeholders to collaborate and lead the activities required to successfully deliver product that meets the clinical and commercial demand forecasts.
This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.
WHAT YOU'LL DO- Serve as CDMO site leader across the contract manufacturing lifecycle (decide, select, transfer, manage, exit) to establish robust partnerships and ensure delivery per Vir Bio milestones and performance metrics
- Lead day-to-day manufacturing operations within Vir Bio’s network of CDMOs for clinical and future commercial supply
- Identify and support manufacturing improvements and lifecycle management: productivity, efficiency, COGM reduction, etc.
- Lead a cross-functional team across Technical Operations and Stakeholders to implement program strategy, and ensure team meets responsibilities to support successful on-time delivery of product
- Continuously identify improvement opportunities and implement external manufacturing policies, business processes and systems
- Provide Vir leadership of Joint Project Teams with stakeholder representatives from Vir and CDMO(s); implement clear communication strategy, issue resolution, documentation of decisions, and ongoing risk-management to ensure delivery on time and in budget
- Establish and maintain CDMO site performance dashboards
- Work with the external operations and transactional law teams to establish development and supply contracts and statements of work (SOW)
- Prepare and support purchase requests for procurement of materials and services through Vir standard tools (Coupa and NetSuite); invoice management with our CDMO’s, CTL’s, and suppliers
- Identify and support the onboarding of new CDMO(s) in Vir quality management system and manage change notifications for existing Vir vendors; tracks metrics to monitor CDMO operational performance and compliance status
- Manage GxP document control, storage, archival, retention, access and handling for CDMO cGMP manufacturing operations
- BS and 10+ years of in the biotech/pharmaceutical industry with GMP manufacturing operations experience, particularly in monoclonal antibodies with mammalian and microbial, siRNA, and bi-specifics a plus
- Experience in antibody and siRNA commercialization
- Knowledge of cGMP quality systems
- mAb, siRNA, bi-specific, mammalian and microbial host experience preferred
- Knowledge and experience in outsourced manufacturing and testing preferred
- Excellent interpersonal, verbal and written communication skills
- Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
- Commercialization experience through launch; filing authorship, RTQ, PAI
- Up to 15% domestic and international travel may be required
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.
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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
