Scientist, Bioanalytical Development

Responsibilities

• Develop ligand binding methods including pharmacokinetic (PK), immunogenicity (ADA) and pharmacodynamic (PD) assays.
• Design and independently execute experiments to select/identify appropriate bioanalytical reagents.
• Oversee and perform sample analysis from preclinical and clinical studies.
• Design and implement specialized in vitro studies designed to enhance mechanistic understanding of drug development candidates as needed on development programs.
• Analyze data and trouble shoot assay development activities.
• Write reports summarizing data and methods.
• Manage and oversee activities of Research Associates.
• Implement innovative technologies which offer pragmatic enhancements to the bioanalytical department.
• Manage ongoing bioanalysis at external vendors to support large molecule drug candidates.
• Negotiate CRO contracts and SOWs; from approval to execution.
• Review, edit, and finalize method validation protocols, amendments, and reports, ensuring that documents meet project timelines, expectations, and deliverables, as well as Visterra’s global regulatory and compliance requirements.

Requirements

• A minimum of 5 years of working experience, including hands-on laboratory experience in the bioanalysis or biotechnology industry.
• An M.S. or Ph.D. in Immunology, Biology, Biochemistry, or related field is preferable, although candidates with a Bachelor of Science (BS) degree with significant research experience are also encouraged to apply.
• Experience with ligand binding method development using ELISA and MSD.
• Working experiences with biologics.
• Proven experience in the development and validation of regulated bioanalytical method assays for pharmacokinetic, pharmacodynamic and immunogenicity evaluation.
• Experience with summarizing data in slides and reports.
• Experience with vendor management and project management.
• Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Bioanalytical development in support of clinical trials.
• Extensive experience with a broad range of bioanalytical platforms including ELISA, MSD and Flow Cytometry and techniques including bridging, direct, indirect, and competitive assays.
• Ability to manage a research associate as a direct-report, including assigning and reviewing tasks and mentoring and coaching.
• Strong time management and organizational skills, attention to accuracy and detail, and the ability and willingness to multi-task as needed.
• This individual will be highly analytical, goal-oriented, and timeline sensitive while maintaining high quality standards.