Senior Scientist I, Bioanalytics
San Francisco, United States
Job Description
Vir is seeking a Senior Scientist I, Bioanalytics who will develop bioanalytical methods to support our large molecule assets. You will oversee the development, and reporting of bioanalytical analyses, including contribution to regulatory documents, and will ensure reliable data are provided to end-users in accordance to GXP requirements. You will manage external vendors, participate in vendor audits, and manage all aspects of method development, validation, study sample analysis of data. You will report to the Senior Director, Bioanalytics.
This is an onsite role and you will work a few days each week from our HQ in San Francisco.
WHAT YOU'LL DO
- Develop bioanalytical methods to support large molecule clinical candidates and providing bioanalytical input across all departments and stages of research and development.
- Coordinate method development and analysis activities within the context of development plans.
- Perform troubleshooting and evaluation of a variety of complex methods to identify appropriate bioanalytical solutions.
- Lead technology transfer of bioanalytical methods.
- Interact with internal Research, CMC, Operational, and Regulatory groups to support drug development activities.
- Responsible for approval of data and reports from external vendors.
WHO YOU ARE AND WHAT YOU BRING
- PhD with 5+ years /MS and 8+ years/BS and 10+ years of industry experience.
- Experience must include a combination of laboratory and project management skills, including managing CROs for assay development and validation for clinical and non-clinical studies.
- Demonstrated expertise in GLP and GCP compliance of sample handling and storage, bioanalytical assay development, sample analysis, and laboratory operation and procedures is required.
- Technical expertise with several platforms to analyze all aspects of large molecule therapeutics, including those with complex sample handling and preparation procedures (e.g., enzymatic assays, ligand-binding assays, cell-based assays) from a variety of biological matrices (e.g., serum, plasma).
- Familiar with PK and PD principles of establishment of relevant assays and assay ranges.
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WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $164,000.00 to $216,000.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with your experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity and 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 onsite employees!
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Career Focus: Bioanalytics, Quality, Scientist
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