MANAGER, QC PROGRAM LEAD

Vir Biotechnology

San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Life Sciences QA/QC
  • Post Date: 02/04/2021
  • 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 innovative technologies. We have assembled four technology platforms that are designed to stimulate and improve the immune system by exploiting critical observations of natural immune processes. Our current development pipeline consists of product individuals targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis.
 
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 Quality Control professional to perform QC activities in support of our multiple modality platform to infectious diseases. This individual will coordinate QC related outsourced laboratory activities and integrate with internal functions of Vir and its partners. The Manager, QC Program Lead will represent the CMC QC and Product Quality function on related project teams and coordinate team objectives with the rest of the organization. 

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

    • Provide technical Quality review and evaluation of lot release testing, stability, and validation studies performed at external vendors.
    • Partner with QA to resolve contract lab deviations, OOS/OOT and lab investigations, and change control in accordance with Vir internal policies.
    • Manage assay transfer, implementation, optimization, and validation of analytical test methods at contract manufacturing organizations and contract test labs.
    • Build and lead programs for the characterization and qualification of reference materials, assay controls, QC cell banks, and critical reagents.
    • Collaborate with Analytical Development on assay qualification, assay system suitability and sample acceptance criteria, and define specifications.
    • Represent QC in team meetings and with cross functional partners.
    • Support Quality audits and technical visits, up to 20% travel may be required.

QUALIFICATIONS AND EXPERIENCE

    • Prior biotech experience in one or more of the following: biologics, therapeutic nucleotides, viral vaccines, or cell and gene therapy.
    • Strong scientific background in Quality Control and/or assay development in the drug development industry with solid understanding of cGMP/ICH/FDA/EMA regulations.
    • Expertise with analytical test method optimization, validation, and transfer as well as working with contract organizations.
    • Great teammate with ability to work in a collaborative, fast-paced team environment
    • Experience with representation/leadership on inter-disciplinary and cross-functional program teams
    • 8+ years Quality Control, CMC, or Quality background in pharma/Biotech industry and 5+ years direct hands on experience in QC, Analytical Development, or a Product Quality role.
    • BS/MS in relevant scientific field 
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.

Related Jobs

SENIOR DIRECTOR, CMC TEAM LEADER

Vir Biotechnology - San Francisco, CA, US

Lab Manager

Vir Biotechnology - Portland, OR, US

DIRECTOR, CLINICAL QUALITY ASSURANCE (CQA)

Vir Biotechnology - San Francisco, CA, US

MANAGER, QC PROGRAM LEAD

Vir Biotechnology - San Francisco, CA, US

SENIOR MANAGER, GLOBAL PRODUCT STRATEGY

Vir Biotechnology - San Francisco, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.