What are the responsibilities and job description for the Director, Analytical Development position at virbiotechnologyinc?
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 infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections 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 seeking an experienced technical Director to support the late-stage analytical activities and provide input and direction to the overall Analytical Development, Sciences & Technology strategy. In this role, the individual will be a matrix leader and technical writer working collaboratively with the Chemistry, Bioassay and Data Analytics teams to develop the analytical control strategy, justification of specifications, CQA risk assessments, analytical comparability and structure-function relationship studies and author associated protocols/reports. The Director will also work collaboratively with the teams to develop phase-appropriate road maps for the transition from early stage to pivotal trials. With knowledge of regulatory requirements for late-stage BLA/NDA-enabling analytical deliverables, the Director will work with the functional area leads to identify/mitigate risks and author associated sections of global regulatory submissions.
This role is based in our San Francisco office with the expectations to be onsite 4 days a week.
WHAT YOU'LL DO
- Provide strategic and technical input to the Analytical Development, Sciences and Technology team on characterization, comparability and analytical control strategies for recombinant antibodies, siRNA and dual-masked T-cell engagers
- Design and author protocols/summary reports for BLA-enabling characterization studies such as structure-function relationship, impurities characterization, forced degradation and comparability studies executed by AD-Chemistry and AD-Bioassay teams
- Collaborate cross-functionally to develop CQA risk assessments, specifications and author specification justification reports
- 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 with input from SMEs
- Author risk assessments, post-approval change protocols for late stage and commercial comparability
WHO YOU ARE AND WHAT YOU BRING
- PhD in a relevant scientific discipline with >10 years of experience in biotech industry is preferred or MS with >15 of biotech industry experience
- In-depth understanding of protein structure, function and technical expertise in characterization, release and stability testing
- Experience with oligonucleotides (siRNA or ASO) is a plus
- Experience authoring technical reports such as comparability protocols/reports, structure function relationship study reports, CQA risk assessments
- Experience authoring global regulatory filings and responses to questions, knowledge of requirements/expectations for characterization, release and stability testing and specifications
- Applied knowledge of ICH and regulatory guidelines, QbD principles
- Prior experience working with matrix teams
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $207,500 to $261,500. 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. 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.
Candidate Privacy Notice
Salary : $207,500 - $261,500
