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ASSOCIATE DIRECTOR, CMC COVID TEAM LEADER

Vir Biotechnology is a clinical-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. Our current development pipeline consists of five product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.

Vir Biotechnology is seeking a CMC Team Leader to drive cross-functional CMC activities for Vir's Covid antibody programs. If you've ever considered transitioning from a functional SME to a role in CMC project leadership, this could be the role for you. This development opportunity will involve shadowing the VP of CMC Strategy and Operations over a period of several months prior to taking on full team lead responsibilities for internal and joint CMC teams on a fast-paced, complex program involving multiple external stakeholders. Specifically, this role will involve management of all project aspects related to CMC, including process development, analytical development, technology transfer, manufacturing, regulatory submissions, and clinical and commercial supply. This newly-created position is a leadership role in a matrixed environment and will report to the Vice President of CMC Strategy & Operations.

RESPONSIBILITIES

    • Leads the internal cross-functional CMC Covid antibody project team, and works with a development partner to co-lead a joint CMC team.
    • Working with external partners and stakeholders, develops and implements CMC strategies required for execution of project deliverables to accelerated timelines.
    • Leads the development and coordination of CMC's goals at the asset Program Team level and closely monitors progress against these goals for operational efficiency ensuring the CMC team delivers on time, within scope, and on budget.
    • Drives the development and execution of high quality, integrated, cross-functional project plans that capture all CMC activities, including integration of partner / vendor activities, and ensures alignment with the overall program strategy.
    • Anticipates and identifies issues, develops contingency and risk mitigation plans, and communicates the potential impact to the relevant governance committees.
    • Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance.
    • Represents the CMC functions on the Program Team; collaborates closely with other Program Team members to define and deliver the project strategy, objectives and plans; ensures that the CMC timelines and strategy are aligned with the Program Team objectives and corporate goals.



QUALIFICATIONS AND EXPERIENCE

    • 10 - 12 years of experience in the pharmaceutical industry with prior experience as a CMC team leader.
    • Strong technical knowledge of CMC development, CMC Regulatory Affairs, Quality, and/or Biotech Operations within the pharmaceutical or biotech industries.
    • Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills.
    • Excellent verbal and written communication skills with success in influencing others in cross-functional areas.
    • Proven ability to succeed in a fast-paced, challenging and complex matrixed team environment.
    • Strong collaborative and relationship-building skills.
    • Proven ability to work proactively and think strategically.
    • 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.
    • Experience managing projects with remote teams and through external alliances preferred.



EDUCATION

    • BS or MS in Biotechnology, Chemical Engineering, Biology, or Chemistry; additional/postgraduate qualifications will be a distinct advantage.



Vir is a company with a compelling mission, "A World Without Infectious Disease". We believe the success of our colleagues drives the success of our business. This is reflected in our ongoing commitment to creating an environment focused on equality, inclusion, and respect. When everyone feels supported and inspired to contribute at their best, we will collectively deliver amazing results.

Vir is committed to attracting and employing a diverse workforce to strengthen our values and mission. Qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disability.

The Human Resources team manages the recruitment and employment process 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 Recruiters not contact or present candidates directly to our hiring manager or employees.

ASSOCIATE DIRECTOR, CMC COVID TEAM LEADER

San Francisco, CA
Full Time

Published on 11/05/2020