Vir is looking for a Scientist of Bioanalytics who will develop bioanalytical methods to support development of large molecule assets. You will oversee the development, validation and reporting of bioanalytical analyses, including contribution to regulatory documents, and will work across departments to ensure reliable data are provided to end-users in accordance to GXP requirements. You will help manage external vendors, participate in vendor audits, and manage all aspects of method development, validation, study sample analysis, and reporting of data. You will report to the Senior Scientist, Bioanalytics.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES:
- Develop bioanalytical methods to support large and small molecule clinical candidates and providing bioanalytical input across all functional areas and stages of research and development
- Perform sample bioanalysis to support non-clinical drug development activities
- Coordinate method development and analysis activities within the context of development plans
- Generate and characterize critical reagents to support the assay development and life cycle maintaineces (eg. Labeling)
- Perform troubleshooting and evaluation of a variety of complex methods in order to identify appropriate bioanalytical solutions
- Lead technology transfer of bioanalytical methods, as appropriate
- Work with internal Research, CMC, Operational, and Regulatory groups to support drug development activities
- Responsible for review of data and reports from external vendors
QUALIFICATIONS AND EXPERIENCE:
- Scientist I:PhD (1+ years) MS (4+ years) and BS (6+years) relevant industry experience
- Scientist IIPhD (3+ years) MS (6+ years) and BS (8+years) relevant 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/processes is required
- Technical expertise with a variety of 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, etc.) from a variety of biological matrices (e.g., serum, plasma, etc.). Small molecules expertise is a plus
- Technical expertise with critical reagent generation (labeling) and characterization is preferred
- Familiar with PK and PD principles pertaining to establishment of relevant assays and assay ranges
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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.
