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 Bio is looking for a Temporary Senior Specialist, Quality Operations (12+ Month Initial Contract) who will support quality oversight activities related to manufacturing, testing, packaging, and labeling operations at Vir Biotechnology and Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and suppliers. This individual will partner with cross-functional teams to help ensure products are manufactured, tested, and released in compliance with current Good Manufacturing Practices (cGMPs) and applicable regulatory requirements.
You will contribute to quality review and approval activities, support issue management and investigations, and help maintain quality systems that support clinical and commercial products across our development portfolio.
This role is based in our San Francisco, California office with the expectation to be onsite three days per week.
WHAT YOU'LL DO
- Support quality oversight of manufacturing, testing, packaging, and labeling activities performed by CMOs, CTLs, and suppliers
- Review quality records including deviations, CAPAs, change controls, investigations, and SOPs
- Review manufacturing and testing documentation, including batch records and supporting release documentation
- Support batch disposition and release activities
- Review validation protocols and reports, including process, method, and cleaning validation activities
- Collaborate with cross-functional teams to address quality issues and support ongoing operations
- Assist with supplier quality management activities and Quality Agreement maintenance
- Support internal audits, supplier audits, and regulatory inspection readiness activities
- Escalate quality issues and compliance risks to management as appropriate
- Contribute to continuous improvement initiatives within the Quality organization
WHO YOU ARE AND WHAT YOU BRING
- Bachelor's degree in a scientific discipline and 5+ years of experience in Quality Assurance, Quality Operations, Manufacturing, or a related GMP-regulated pharmaceutical or biotechnology environment preferred
- Experience supporting GMP manufacturing and testing activities
- Familiarity with quality systems including deviations, CAPAs, change controls, investigations, and document management
- Working knowledge of cGMP regulations and quality principles
- Strong organizational, communication, and collaboration skills
- Experience working with CMOs, CTLs, or suppliers preferred
WHO WE ARE AND WHAT WE OFFER
The expected hourly range for this position is $52.00 to $70.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
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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Skills Required
- Bachelor's degree in a scientific discipline
- 5+ years of experience in Quality Assurance, Quality Operations, Manufacturing, or a related GMP-regulated pharmaceutical or biotechnology environment
- Experience supporting GMP manufacturing and testing activities
- Familiarity with quality systems, including deviations, CAPAs, change controls, investigations, and document management
- Working knowledge of cGMP regulations and quality principles
- Strong organizational, communication, and collaboration skills
- Experience working with CMOs, CTLs, or suppliers
- Current authorization to work for any employer in the United States without employment visa sponsorship
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
