Bioanalytical Development Scientist at Visterra
Overview
Visterra seeks a Scientist, Bioanalytical Development to lead PK ADA and PD assay development for preclinical and clinical programs. This full-time role in Waltham, MA involves designing and executing bioanalytical methods for large molecule drug candidates, managing research associates, and overseeing vendor relationships. The ideal candidate possesses deep expertise in ELISA and MSD techniques and drives method optimization to support IND filings and clinical development.
What You'll Do11
- 1Develop ligand binding methods including pharmacokinetic ADA and pharmacodynamic assays
- 2Design and execute experiments to select bioanalytical reagents and validate assays
- 3Oversee sample analysis from preclinical and clinical studies
- 4Implement specialized in vitro studies to enhance mechanistic understanding of drug candidates
- 5Analyze data troubleshoot assay development activities and produce comprehensive reports
- 6Manage Research Associates through direct reporting and mentorship
- 7Negotiate CRO contracts and service level agreements from approval to execution
- 8Review and finalize method validation protocols meeting regulatory standards
- 9Maintain compliance with GLP GCP ICH guidelines throughout bioanalytical processes
- 10Collaborate across departments to integrate bioanalytical findings into clinical development plans
- 11Travel to conferences and vendor sites as required for technical advancement
Requirements11
- 1Minimum 5 years of hands-on bioanalysis experience in biotechnology or pharmaceutical industry
- 2M.S. or Ph.D. in Immunology Biology Biochemistry or related field preferred
- 3Proven experience with ELISA MSD Flow Cytometry and bridging direct indirect competitive assays
- 4Expertise in ligand binding method development for PK ADA and PD evaluations
- 5Demonstrated ability to manage research associates and project timelines
- 6Strong knowledge of vendor management and contract negotiation processes
- 7Familiarity with regulatory requirements for bioanalytical method validation
- 8Experience with large molecule drug candidate analysis and clinical trial support
- 9Ability to work in a fast-paced environment with emphasis on precision and documentation
- 10Flexibility to travel for conferences and vendor engagements
- 11Excellent analytical skills and attention to detail for accurate data interpretation
Salary Insight
Salary not disclosed in listing
Location
Required Skills
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