SENIOR SPECIALIST, QC SYSTEMS

Vir Biotechnology

San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 03/29/2021
  • Website: vir.bio
  • Company Address: 499 Illinois Street, Suite 500, San Francisco, CA 94158

About Vir Biotechnology

Vir Biotechnology brings together cutting-edge innovations with scientific expertise and management.

Job Description

Vir is a clinical-stage immunology company with a compelling mission: “A World Without Infectious Disease”. We are focused on combining immunologic insights with cutting-edge technologies. We have 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 product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
 
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 Biotechnology is seeking a Senior Specialist of Quality Control Systems to support Vir’s QC and Product Quality programs. In this role you will have the exciting and unique opportunity to build and maintain QC systems and processes related to management of method lifecycle, specifications, reference standard, and contract test labs to support clinical development activities across multiple drug modalities. 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Author and review documents for analytical method transfer, qualification, and validation to support method transfer activities at contract organizations.  
    • Author and establish standard operating procedures, protocols, and reports to support a variety of therapeutic modalities, including viral vectors, antibodies, and siRNA.
    • Ensure consistency in requirements through oversight and review of method lifecycle activities including method qualification, transfer, and validation, as well as systems for establishing system suitability and assay trending programs.
    • Work collaboratively with program leads, QA, and project managers to support method lifecycle management, including contributing to regulatory submissions and regulatory agency responses.

QUALIFICATIONS AND EXPERIENCE

    • Bachelor’s degree in a scientific discipline (chemistry or biology focus preferred) or other relevant degree.
    • 3-5 years of experience in a GMP environment with a background in related Quality Control systems.
    • Experience with method lifecycle, reference standard and specification management to current GMP requirements.
    • Startup experience preferred with demonstrated knowledge of cGMP/ICH/FDA/EU regulations, as well as USP, EP, and JP monographs.
    • Refined critical thinking skills, with an emphasis on flexibility and risk-based, phase-appropriate approaches to problem-solving.
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.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.