Vir Biotechnology (201-500 Employees, 92% 2 Yr Employee Growth Rate)
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 Analytical Program Lead to oversee the QC-related activities in support of monoclonal antibody programs. The Associate Director will coordinate method validation/transfer and release/stability testing at outsourced QC laboratories and collaborate with cross-functional teams at Vir and its partners. The Analytical Program Lead will represent ADQC at the cross-functional CMC Team, lead the analytical subteam and track analytical deliverables/timelines. The successful candidate will partner with Analytical Development to support internal and external method development, qualification and transfer, selection/qualification of reference standards, and develop the analytical control strategy for drug substance and drug product specifications. In addition, the Analytical Program Lead will partner with QC Stability to establish release/stability specifications and shelf life. Other responsibilities include authoring reports and applicable CMC sections of regulatory submissions.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Manage and provide technical review in support of lot release testing, stability and validation studies performed at external vendors and coordinate with internal groups at Vir and its partners
- Partner with QA to resolve contract lab deviations, OOS/OOT and lab investigations, and change control
- Manage assay transfer, implementation, optimization, and validation of analytical test methods at contract testing labs
- Lead the characterization and qualification of reference materials, assay controls, and critical reagents used in the QC labs
- Collaborate with QC Stability and Analytical Development to create assay trending programs, define assay system suitability criteria, and define specifications
- Represent QC on project teams and in other cross-functional forums
- Author regulatory filing sections and responses to regulatory questions
- Support Quality audits and technical visits
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.
- Technical expertise in a wide range of analytical methods for release and stability testing of monoclonal antibodies
- Strong scientific background in Quality Control and/or assay development in biotech industry with strong knowledge of cGMP/ICH/FDA/EMA regulations
- Expertise with analytical test method optimization, validation, and transfer as well as working with contract organizations
- Strong written/verbal communication skills and experience with representation/leadership on cross-functional program teams
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.
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.