Director, CMC Team Leader

Vir Biotechnology, Inc. San Francisco , CA 94118

Posted 2 months ago

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 hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis.

Vir Biotechnology is seeking an experienced CMC Team Leader to drive cross-functional CMC activities for one or more of Vir's programs from early stage development through commercial life cycle. 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 Head of CMC Strategy & Operations.

RESPONSIBILITIES

  • Leads cross-functional CMC project teams in developing and implementing CMC strategies and activities associated with Vir's multi-modality portfolio.

  • 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.

  • Ensures all appropriate team member views have been raised and incorporated into team decisions as appropriate at all Governance levels.

  • Facilitates robust communication, both within CMC department and with other key stakeholders, to ensure all functions are aware of changes in strategy and impacts to risks and resources.

  • 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.

  • Provides regular updates to the Program Team and the relevant governance committees; communicates the CMC strategy and activities to external partners as needed.

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

  • 12 - 15 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.

  • Demonstrated ability to lead cross-functional teams.

  • 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.

VIR is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.


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Director, CMC Team Leader

Vir Biotechnology, Inc.