Associate Director, External Operations

Vir Biotechnology•San Francisco, CA

5h•Hybrid

About The Position

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. THE OPPORTUNITY 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.

Requirements

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

Responsibilities

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