Senior Scientist, Bioanalytical
The Senior Scientist, Bioanalytical is responsible for performing laboratory activities and experiments related to the development and scientific qualification of bioanalytical methods for preclinical/clinical programs. The Senior Scientist, Bioanalytical will be responsible for activities related to the supervision of internal laboratory conduct and the management of external bioanalytical vendors in support of drug development candidates. They will supervise and coordinate the execution of experiments to support IND filings and early pre-clinical development. They will also 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 managing the development of bioanalytical methods for programs in preclinical and clinical development, documenting the methods used and summarizing the data collected within study reports. This individual will be responsible for the supervision and planning 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.
- Select/identify appropriate bioanalytical reagents. Lead outsourcing activities to establish custom reagents.
- Design and implement specialized in vitro studies designed to enhance mechanistic understanding of drug development candidates as needed on development programs.
- Issue reports summarizing laboratory results as appropriate.
- Manage a team of junior analysts.
- Coordinate ongoing internal bioanalysis.
- 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.
- A minimum of 6 years of working experience, including hands-on laboratory experience in the bioanalysis or biotechnology industry.
- Bachelors degree in Immunology, Biology, or related field of study.
- Working experiences with biologics.
- 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.
- Experience with a broad range of bioanalytical platforms and techniques including ELISA, MSD and Flow Cytometry.
- 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.
Visterra is a clinical stage biotechnology company committed to developing innovative biologic therapies (monoclonal antibodies and therapeutic muteins) for the treatment of kidney diseases, with an immuno-nephrology focus in drug development. Our proprietary technology platform enables the design and engineering of precision antibody or protein-based drug candidates to modulate key disease targets. 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 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.