Vir Biotechnology, Inc.
Associate Director, Analytical Development
Vir Biotechnology, Inc., San Francisco, California, United States, 94199
Associate Director, Analytical Development
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. THE OPPORTUNITY
Vir Biotechnology is looking for an Associate Director, Analytical Development to support 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 responsible for in-house studies on structure-function, impurities characterization, forced degradation, and comparability studies, while actively participating in lab work alongside your team fostering their scientific development. 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 you and your team. 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. WHO YOU ARE AND WHAT YOU BRING
PhD in a relevant scientific discipline with 7+ years of experience in biotech industry is preferred or MS with 10+ years of biotech industry experience In depth understanding of antibody structure, function and technical expertise in characterization, release and stability testing is required Technical understanding and industry experience with oligonucleotides (siRNA or ASO) is strongly preferred Applied knowledge of ICH and regulatory guidelines, QbD principles Prior experience in leading and managing both projects and scientific teams Willingness to actively participate in lab based work while also driving programs forward These bullets may be followed by location or visa language as applicable. WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $177,500 to $222,500. 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. External recruiters and/or agencies should 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. Interested in building your career at Vir Biotechnology? Get future opportunities sent straight to your email. Apply for this job
indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred first name Highest level of education completed * Are you legally authorized to work in the US? * Will you require sponsorship to work in the US now or in the future? * What are your salary expectations? What city and state do you live in? * Are you able to work at least 4 days a week at our San Francisco headquarters? * Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Vir Biotechnology’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. A "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. Disabilities include, for example, ADHD, autism, dyslexia, etc. This list is not exhaustive. PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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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. THE OPPORTUNITY
Vir Biotechnology is looking for an Associate Director, Analytical Development to support 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 responsible for in-house studies on structure-function, impurities characterization, forced degradation, and comparability studies, while actively participating in lab work alongside your team fostering their scientific development. 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 you and your team. 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. WHO YOU ARE AND WHAT YOU BRING
PhD in a relevant scientific discipline with 7+ years of experience in biotech industry is preferred or MS with 10+ years of biotech industry experience In depth understanding of antibody structure, function and technical expertise in characterization, release and stability testing is required Technical understanding and industry experience with oligonucleotides (siRNA or ASO) is strongly preferred Applied knowledge of ICH and regulatory guidelines, QbD principles Prior experience in leading and managing both projects and scientific teams Willingness to actively participate in lab based work while also driving programs forward These bullets may be followed by location or visa language as applicable. WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $177,500 to $222,500. 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. External recruiters and/or agencies should 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. Interested in building your career at Vir Biotechnology? Get future opportunities sent straight to your email. Apply for this job
indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Preferred first name Highest level of education completed * Are you legally authorized to work in the US? * Will you require sponsorship to work in the US now or in the future? * What are your salary expectations? What city and state do you live in? * Are you able to work at least 4 days a week at our San Francisco headquarters? * Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. As set forth in Vir Biotechnology’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. A "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp. Disabilities include, for example, ADHD, autism, dyslexia, etc. This list is not exhaustive. PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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