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VICE PRESIDENT, PHARMACEUTICAL DEVELOPMENT (CMC)

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.

Vir Bio is seeking an experienced scientist or engineer to lead drug product development and be accountable for all of Vir's pipeline of products with a focus on formulation of drug substance, drug product and drug process development and product configuration. This role covers Vir's entire pipeline which includes a diverse set of therapeutic modalities (antibodies, viral vectors, and nucleic acids). This individual is accountable for the development of early stage and late stage/commercial processes, including accountability for the process characterization and validation studies in support of the biologics license applications which are primarily carried out at contract manufacturing organizations. As the department head, this individual will be responsible for supporting due diligence activities associated with acquisitions, partnerships and collaborations with external partners. They will provide cross-functional support to drug substance development, analytical development/QC, and CMC regulatory affairs. She/he will review protocols, technical reports, and regulatory submissions to support clinical development and licensure.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Provide technical leadership in formulation development to support pre-clinical and clinical programs at all development stages, drug product process development and characterization.
    • Responsible for the design, execution and delivery of formulation and process development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats), viral vectors, and nucleic acids.
    • Work with non-clinical and clinical teams to design and execute studies to support product use and stability.
    • Build and manage interfaces with Manufacturing and a network of CDMOs
    • Direct outsourced drug product development with Contract Manufacturing Organizations including formulation development, container closure/device development and preparation of Chemistry, Manufacturing and Controls (CMC) programs for drug products in development.
    • Develop and implement formulation, primary packaging (container closure system), and dosage form configurations to ensure stability, manufacturability, and reliability.
    • Participate in multi-disciplined project teams, and guide project strategies.
    • Facilitate collaboration with both internal and external drug product analytical teams, quality control and assurance, and manufacturing.
    • Ensure that appropriate technical strategies and timelines are in place to meet clinical supply and registration needs, and that production, technology transfer and regulatory outcomes meet or exceed industry standards.
    • Authoring CMC sections describing the pharmaceutical science studies supporting the drug product formulation, process and controls, container closure integrity, in-use studies, and product stability/expiry.
    • Participate in cross-functional due diligence teams during evaluation of potential partnerships or acquisitions
    • Drive talent acquisition, development and retention



QUALIFICATIONS AND EXPERIENCE

    • B.S., M.S or Ph.D. in pharmaceutical sciences, biochemistry, chemistry, chemical engineering or related fields and 18+ years industrial experience
    • 15+ years of experience in protein or viral vaccine formulation and drug product development is required. Experience with multiple therapeutic modalities is a plus.
    • Extensive understanding of drug degradation pathways and design of accelerated stability and excipient screening studies
    • Experience operating in early, late stage and commercial cGMP clinical programs
    • Significant proficiency in drug product processing unit operations including filling, lyophilization, capping
    • Strong biophysical and biochemical protein analytical skills
    • Demonstrated technical, functional and project leadership experience to develop integrated short term and long term project plans for preclinical, clinical and commercial programs
    • Proven track record of leading a staff of scientists/engineers and managing multiple concurrent technical projects
    • Extensive management and leadership experience which cultivates and drives adoption to change, building of resiliency skills
    • Demonstrated ability to hire top talent, developing others and building a successful organization
    • Brings international experiences, and has forged strong connections with internal and external business partners



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.

VICE PRESIDENT, PHARMACEUTICAL DEVELOPMENT (CMC)

Remote, OR 97458
Full Time

Published on 11/25/2021

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