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Director, Formulation and Drug Product Development

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 to lead drug product development and be accountable for the pharmaceutical development of all of Vir's pipeline of products with a focus on biologics drug substance and drug product formulation development. This pipeline includes a diverse set of therapeutic modalities (antibodies, cell therapies, viral vectors, and nucleic acids). The candidate will initially work primarily with third parties (e.g., CDMOs and suppliers), while collaborating with cross-functional CMC teams to lead projects in-house. The director will provide cross-functional support to quality control, analytical development, process analytics, and other functions. They will author and review protocols, technical reports, and regulatory submissions to support clinical development and licensure.

RESPONSIBILITIES:

  • 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.
  • Supervise outsourced drug product development with Contract Manufacturing Organizations
  • 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 for regulatory filings


QUALIFICATIONS AND EXPERIENCE:

  • 20 years + (BS); 17+ years (MS); 12+ years (PhD) 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 both early and late-stage 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 scientists/engineers and managing multiple concurrent technical projects



This role may be performed remotely if VIR can support remote work arrangements in the state where you currently reside. This includes most states within the US. If you move forward in the hiring process, VIR recruiters will discuss options with you.

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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, 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.

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Director, Formulation and Drug Product Development

San Francisco, CA
Full Time

Published on 09/20/2022

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