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SENIOR SCIENTIST/ENGINEER, DRUG SUBSTANCE TECHNOLOGY TRANSFER

San Francisco, CA CMC - Process Development Full Time
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 is seeking a key member of the CMC team to transfer both upstream and downstream cGMP processes for the production of therapeutic mAb Drug Substance for treatment of pandemic infectious diseases. This individual will join a team responsible for the technology transfer of manufacturing processes into a global network of Drug Substance production facilities together with Vir’s business partners. Your knowledge of process development and engineering, manufacturing technology and validation support will support the rapid definition and execution of a commercial manufacturing strategy for very large scale mAb production. You will provide technical input into the facility fit and equipment design, support site operational readiness (equipment, process understanding etc.), and prepare regulatory filings supporting product licensure. The role requires flexibility to travel to partner sites in US/Europe/Asia and participation in meetings while working from home. Applicants who do not live in northern California will be considered.


RESPONSIBILIITIES
  • Capture all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at Vir’s partner sites.
  • Assist in technology transfer, including gap analysis and process transfer risk assessment.
  • Ensure the process automation meets the requirements of the process 
  • Provide input to equipment specifications, specification of key components, verification documentation and establishment of process parameter ranges. 
  • Provide technical training on process and technology areas as required by the project. 
  • Draft filing submissions and assist with inspection readiness activities.
  • Contribute to process investigations and support the implementation of CAPAs. 
  • QUALIFICATIONS/EXPERIENCE
  • Experience working in a mAb manufacturing facility or process development environment. 
  • Familiarity with mAb cell culture and/or purification technology
  • Knowledge of process validation requirements and execution for cGMP mAb production
  • Experience in technology transfer or process development is a requirement
  • Strong evidence of problem-solving skills
  • Good communication skills 
  • EDUCATION
  • A B.S, M.S or Ph.D. in Biosciences, Chemical Engineering with 5+ years of experience 

  • 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.