Associate Scientist, Bioanalytical Development

We are a team of 85 talented and driven people working passionately and collaboratively to develop a robust pipeline of innovative antibody-based therapies for patients with unmet needs.  Our proprietary technology platform powered by our state-of-the-art laboratory enables the design and engineering of precision antibody-based product candidates that specifically bind to, and modulate, key disease targets for the treatment of patients with kidney diseases and other hard-to-treat diseases.  Visterra is a subsidiary of Otsuka Pharmaceutical Co., Ltd. of Japan.  As a member of the Otsuka family of companies, we have the advantage of being a dynamic, nimble, innovative organization where you can make direct, meaningful impacts while benefiting from the support, stability, and long-term perspective of a 100-year-old global company.

Summary

The Associate 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.  The Associate Scientist, Bioanalytical Development will be responsible for activities related to the design, development and qualification 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.  They may 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 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, with occasional opportunity to work remotely.

Responsibilities

• Design bioanalytical methods at the direction of the team leader.
• Select/identify appropriate bioanalytical reagents.  
• Manage outsourcing activities to establish custom reagents.
• Conduct specialized in vitro studies, as directed by the team leader, to enhance mechanistic understanding of drug development candidates as needed on development programs.
• Draft reports summarizing laboratory results as appropriate.
• Train junior analysts and team members as needed.
• Suggest innovative technologies which offer pragmatic enhancements to the bioanalytical department.
• Collaborate with external vendors for the transfer of bioanalytical methods to support large molecule drug candidates.
• Track and manage CRO contracts, SOWs, and invoices.
• Review bioanalytical quality documents to ensure that they meet scientific and global regulatory/compliance requirements.
• Other duties and responsibilities as required by departmental and business needs.
• Travel as needed to attend conferences, events and vendor site visits (less than10% travel).

Requirement

• Bachelor’s degree in Immunology, Biology, or related field of study.
• A minimum of 4 years of working experience, including hands-on laboratory experience in the bioanalysis or biotechnology industry.
• Working experiences with biologics.
• Experience with external company collaboration.
• 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.
• Genuine curiosity and strong desire to continuously learn, grow and develop yourself and others.

Benefits

We provide comprehensive benefits and resources to support your work, life, and balance.

• A 401(k) retirement plan with a 10% dollar-for-dollar match.
• Medical, dental and vision benefits, with Visterra contributing 80% to the monthly premium.
• A rich mental & behavioral wellness program.
• Short- and long-term disability programs.
• Group and voluntary life insurance.
• Pre-tax flexible spending and commuter accounts.
• 17 days of personal time, discretionary sick time, and 11 holidays per calendar year. Personal time accrual grows to 22 days after 3 years, with an additional one-time grants of 5 days every 5 years.
• Twelve weeks of paid parental leave for birth or adoption.
• A broad fitness reimbursement program.
• Tuition reimbursement.
• A variety of employee discounts.

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.