Scientist, Bioanalytical Development

About the role

This full-time laboratory position is based in Visterra’s facility in Waltham, MA. The Scientist, Bioanalytical Development will perform laboratory activities and experiments related to the development and scientific qualification of bioanalytical methods for preclinical and clinical programs to assess PK, ADA, and PD in preclinical and clinical samples. The role involves bioanalytical method development and qualification for non-regulated/exploratory methods, sample analysis from preclinical studies, and support of drug development candidates. Reporting to the Associate Director in Bioanalytical Development, this individual will execute experiments to support IND filings, preclinical development, and clinical method development, as well as oversee research associates and manage outsourced methods, including vendor management.

Responsibilities

• Develop ligand binding methods including pharmacokinetic (PK), immunogenicity (ADA), and pharmacodynamic (PD) assays.
• Design and independently execute experiments to select and identify appropriate bioanalytical reagents.
• Oversee and perform sample analysis from preclinical and clinical studies.
• Design and implement specialized in vitro studies to enhance mechanistic understanding of drug development candidates.
• Analyze data and troubleshoot assay development activities.
• Write reports summarizing data and methods.
• Manage and oversee activities of Research Associates.
• Implement innovative technologies to enhance the bioanalytical department.
• Manage ongoing bioanalysis at external vendors to support large molecule drug candidates.
• Negotiate CRO contracts and Statements of Work (SOWs) from approval to execution.
• Review, edit, and finalize method validation protocols, amendments, and reports to meet project timelines, expectations, and Visterra’s global regulatory and compliance requirements.
• Travel as needed to attend conferences, events, and vendor site visits.
• Perform other duties and responsibilities as required by departmental and business needs.

Requirements

• A minimum of 5 years of hands-on laboratory experience in the bioanalysis or biotechnology industry.
• An M.S. or Ph.D. in Immunology, Biology, Biochemistry, or a related field is preferred, though candidates with a Bachelor of Science (BS) degree and significant research experience are also encouraged to apply.
• Experience with ligand binding method development using ELISA and MSD.
• Working experience with biologics.
• Proven experience in the development and validation of regulated bioanalytical method assays for pharmacokinetic, pharmacodynamic, and immunogenicity evaluation.
• Experience 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 such as bridging, direct, indirect, and competitive assays.
• Ability to manage a research associate as a direct report, including assigning and reviewing tasks and providing mentorship.
• Strong time management and organizational skills, attention to accuracy and detail, and the ability to multi-task as needed.
• Highly analytical, goal-oriented, and timeline-sensitive while maintaining high-quality standards.

About the company

Visterra is a clinical-stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney, immune-mediated, and other hard-to-treat diseases. Using a proprietary technology platform, Visterra designs and engineers precision antibody-based product candidates that specifically bind to and modulate key disease targets. The company’s pipeline includes multiple clinical-stage assets and one approved therapeutic, sibeprenlimab. As part of the Otsuka family of companies, Visterra operates as a small, dynamic, and innovative organization where individuals and teams are empowered to make significant impacts while benefiting from the support and stability of a global company with over 100 years of history. Visterra has approximately 105 employees and is located in Waltham, Massachusetts.