Scientist, Bioanalytical Development

Summary The Scientist, Bioanalytical Development is responsible for performing laboratory activities and experiments related to the development and scientific qualification of bioanalytical methods for preclinical/clinical programs to assess PK. ADA and PD in preclinical and clinical samples. The Scientist, Bioanalytical Development will be responsible for activities related to the bioanalytical method development and qualification for non-regulated/exploratory methods and sample analysis from preclinical studies in support of drug development candidates. Reporting to the Associate Director in Bioanalytical Development, this role will be responsible for the execution of experiments to support IND filings / preclinical development as well as clinical method development. They may also oversee the activities of a research associates and perform project management activities for out-sourced methods including vendor management. Visterra is seeking a flexible candidate with a working knowledge of large molecule/biologics analytical techniques and laboratory skills. The primary focus will be developing and performing bioanalytical methods for programs in preclinical and clinical development, documenting the methods used and summarizing the data collected. This individual will be responsible for the execution and documentation of experiments to develop bioassays and the empirical evaluation of custom reagents to support preclinical/clinical method development. This is a full-time laboratory position based in Visterra's facility in Waltham, MA. 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. Other duties and responsibilities as required by departmental and business needs. Travel as needed to attend conferences, events and vendor site visits. 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. 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. Our proprietary technology platform enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets. Applying this technology to disease targets that are not adequately addressed by traditional therapeutic approaches, we are developing a robust pipeline of novel therapies for patients with unmet needs. Visterra's pipeline has multiple clinical-stage assets and one approved therapeutic, sibeprenlimab. As a member of the Otsuka family of companies, we are uniquely positioned as a small, dynamic, nimble and innovative organization where individuals and teams are empowered to make big impacts - while benefiting from the support, strength, stability and long-term perspective of a 100-year-old global company. Visterra has approximately 105 employees and is located in Waltham, Massachusetts. Visterra provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.