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Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.
Vir Biotechnology is looking for a Director, Analytical Development to lead late-stage analytical activities for antibody and siRNA programs. You will be responsible for developing control strategies, conducting CQA and analytical target profile risk assessments, and managing BLA-enabling characterization for Ph3, PPQ, and post-approval comparability. You will oversee a team handling in-house studies on structure-function, impurities characterization, forced degradation, and comparability studies. In this role you will collaborate with CMC teams across process development, formulation, regulatory, and external manufacturing to drive program objectives.
This role is based in our San Francisco office with the expectations to be onsite 4 days a week.
WHAT YOU'LL DO- Lead BLA and NDA enabling laboratory studies performed by your group.
- Identify and mitigate risks prior to commercial filings, author/present technical content for pre-filing regulatory engagement meetings, author associated analytical sections, and author responses to regulatory questions.
- Collaborate cross-functionally to develop CQA risk assessments, specifications and author specification justification reports.
- Collaborate cross-functionally on the analytical control strategy, evaluate PAT and advanced process control opportunities.
- Author risk assessments, post-approval change protocols for late stage and commercial comparability.
- Present updates at cross-functional team meetings.
- Attend/Present at relevant scientific conferences and participate in industry groups.
- Develop and manage a team including performance management, career development and mentorship.
- PhD in a relevant scientific discipline with 10+ years of experience in biotech industry is preferred or MS with 13+ of biotech industry experience
- In depth understanding of antibody structure, function and technical expertise in characterization, release and stability testing
- Technical understanding and industry experience with oligonucleotides (siRNA or ASO)
- Experience in authoring global regulatory filings and responses to questions, knowledge of country-specific requirements/expectations for characterization, release and stability testing and specifications
- Applied knowledge of ICH and regulatory guidelines, QbD principles
- Prior experience in leading and managing both projects and scientific teams
The expected salary range for this position is $207,000 to $261,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology'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 Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, childcare reimbursement, education reimbursement, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to any legally protected characteristics.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology. Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us 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.
For hires based in the United States, Vir Biotechnology, participates in E-Verify.
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