Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio .
We believe the success of our colleagues drives the success of our Mission. We have an ongoing commitment to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give at their best, we will collectively deliver outstanding results.
Based in San Francisco and reporting to a member of the External of Manufacturing group, the Manufacturing Sr. Specialist will provide support for the company's early and late-stage clinical manufacturing activities. The candidate will work to help maintain Vir's network of CDMOs producing phase I-III clinical trial material in collaboration with internal stakeholders with a focus on manufacturing operations (start up, execution, material release).
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Support day-to-day manufacturing operations within Vir's network of CDMOs for early and late stage clinical manufacturing: manufacturing start up, change management, deviation management and batch record review to support lot disposition
- Implement external manufacturing policies, business processes and systems
- Coordinate cross-functional teams and internal/external communications to support external manufacturing operations
- Support and in specific cases may serve as CDMO relationship manager across the contract manufacturing lifecycle (decide, select, transfer, manage, exit)
- Work with the external manufacturing and transactional law teams to establish development and supply contracts and statements of work (SOW)
- Prepare purchase requests for procurement of materials and services through Vir standard tools (Coupa and NetSuite); invoice management with our vendors
- Onboard new vendors in Vir quality management system and manages 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
QUALIFICATIONS AND EXPERIENCE
- BS and 5+ years of in the biotech/pharmaceutical industry with GMP manufacturing operations experience, particularly in monoclonal antibodies with small molecule experience a plus
- Knowledge and experience in outsourced manufacturing preferred
- Knowledge of cGMP quality systems
- 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
- Ability to work independently and under minimal direction and supervision.
- Up to 10% domestic and international travel may be required (post Covid-19 pandemic)
Vir'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 benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all lab essential personnel!
Vir is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact Human Resources to request accommodation.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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.