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DIRECTOR, HEAD CMC PROJECT MANAGEMENT

Vir Biotechnology

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Vir is a clinical-stage immunology company with a compelling mission: “A World Without Infectious Disease”. We are focused on combining immunologic insights with cutting-edge technologies. We have assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.   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. 
Vir Biotechnology is seeking an experienced and dynamic individual to oversee CMC Project Management.  This person will have accountability to establish best practices and tools for CMC Product Strategy Teams such as planning, decision making, communication and risk management.  Additionally, this individual will lead and provide technical oversight to a team of CMC Project Managers to ensure strong team performance in a highly matrixed environment.  This newly created role will report into the Vice President of CMC Strategy & Operations and will have close partnerships with Process & Product Development, External Manufacturing and Supply, Quality, and Clinical Supply colleages within Technical Operations. 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Coach and manage a team of CMC project managers supporting global, cross-functional CMC Product Teams for early and late stage clinical assets
    • Ensure CMC Product Team operational excellence in terms of meeting conduct, decision making, risk assessment and management, and lessons-learned processes with a commitment to continuous improvement
    • Identify and champion best practices, including the use of dashboards, templates, tools, and processes to drive efficiency, alignment, and effective planning and communication
    • Leverage their strong project and organizational knowledge, leadership and facilitation skills to enable CMC project managers to drive alignment, collaboration and  accountability within the program teams resulting in achievement of signficant business goals
    • Focus on continuous improvement of team capabilities by ensuring that team members have the opportunity for training and development to excel in their role as functional leaders and cross-functional team members.
    • Take on CMC Project Management responsibilities for one or more products in development and, as required, lead CMC product strategy activities for early-stage assets.
    • Facilitate decision-making, collaboration, and problem-solving with people at all levels of the organization to accomplish shared program goals

QUALIFICATIONS AND EXPERIENCE

    • 10+ years of experience in CMC development, CMC Regulatory Affairs, Quality, or Biotech Operations within the pharmaceutical or biotech industries, with at least 8 years project or program management experience
    • B.S. or M.S. in Biotech, Chemical Engineering, Biology, or Chemistry; additional/postgraduate qualifications (PhD, MBA, PMP, PMI) will be a distinct advantage.
    • Exceptional project management skills, specifically timeline and budget development and oversight with experience at all phases of the product lifecycle. Experience managing a portfolio of multiple products, and prioritization of activities and resources.
    • Demonstrated competency and hands-on experience with typical CMC activities.  Understanding of cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.
    • Applies technical expertise in project management and contributes to the development of new concepts, techniques and standards.
    • Experience managing projects with remote teams and through external alliances preferred.
    • Previous people management experience required along with a passion for employee development
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, one Friday a month 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.

DIRECTOR, HEAD CMC PROJECT MANAGEMENT

Vir Biotechnology

US only
Apply now