The Senior Research Associate, Bioanalytical Development is responsible for performing laboratory activities and experiments related to the development and scientific qualification of bioanalytical methods for preclinical/clinical programs. This role, reporting to the Principal Scientist, Bioanalytical Development will be responsible for activities related to the development, qualification and analysis for non-regulated/exploratory methods and samples in support of drug development candidates. They will perform the execution of experiments to support IND filings and early pre-clinical development.
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.
- Perform laboratory experiments as directed by the Bioanalytical leader.
- Conduct experiments to develop large molecule bioanalytical methods.
- Perform routine care for equipment/platform to support state of the art bioanalytical methods.
- Conduct method qualification.
- Collaborate, as needed, with external vendors for the transfer of primarily ELISA/ECL based PK, ADA and biomarker assays to support large molecule drug candidates.
- Perform internal testing of preclinical samples.
- Maintain inventory of critical reagents for Bioanalysis.
- Other duties and responsibilities as required by departmental and business needs.
- A minimum of 1 year of working experience, including hands-on laboratory experience in the bioanalysis or biotechnology industry.
- Bachelor’s degree in Immunology, Biology or related field of study.
- Working experiences with biologics is highly desirable.
- Knowledge of regulatory requirements, including GLP, GCP, ICH and other applicable guidelines for Bioanalytical development in support of clinical trials.
- Experience with ECL and ELISA assays preferred.
- 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.
- Limited travel (< 5%) may be required to attend conferences and industry events.
Visterra is a clinical stage biotechnology company committed to developing innovative antibody-based therapies for the treatment of patients with kidney diseases 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 is a wholly owned subsidiary of Otsuka America, Inc., which is a U.S. holding company and a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan. Visterra has approximately 110 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.