Associate Director, Stability and Data Analytics

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 Biotechnology is seeking an experienced technical scientist for the role of Associate Director, Stability and Data Analytics supporting a variety of therapeutic modalities, including viral vectors, antibodies, and siRNA. In this role you will have the exciting and unique opportunity to develop strategies related to stability and shelf-life and employ statistical approaches for establishing DS and DP release and stability specifications. This is a critical role that supports early to late-stage clinical programs/trials and collaborates across cross-functional teams to deliver to program and corporate objectives.  

RESPONSIBILITIES AND LEARNING OPPORTUNITIES

• Design and execute innovative stability and specification strategies to support a variety of therapeutic modalities, including viral vectors, antibodies, and siRNA
• Responsibilities include but are not limited to the establishment of protocols, shelf-life/shelf-life (SL/SLE) extensions, statistical data analysis, and trending.
• Author relevant regulatory filing sections and response to regulatory questions
• Author stability comparability assessments in support of DS and DP changes
• Collaborate with CMC team SMEs/stakeholders on SL/SLE and temperature excursions
• Work with external partners to ensure proper testing and reporting of stability samples
• Perform complex statistical analysis to support method bridging, stability model selection, specification establishment and investigations

QUALIFICATIONS AND EXPERIENCE

• BA/BS with >12 years experience, MA/MS/MBA with >10 years experience or PhD with >7 years in Biochemistry, Chemistry, Biology, Virology, Chemical Engineering or a related discipline is preferred.
• Applied knowledge of regulations and requirements for stability and specifications for biologics, oligonucleotides or viral vaccines
• Prior experience overseeing stability programs
• Demonstrated knowledge of cGMP/ICH/FDA/EMA regulations
• Critical thinking skills, with an emphasis on flexibility and risk-based, phase-appropriate approaches to problem-solving
• Self-directed individual who can work independently in a fast-paced, goal-oriented environment

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.