Apply on Employer Site

Upstream Bio · 3 days ago

Principal Scientist/Associate Director, Bioanalytical Sciences

Waltham, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$171K/yr - $209K/yr

4+ years exp

Upstream Bio is a clinical-stage biotechnology company focused on developing treatments for inflammatory diseases. They are seeking a Principal Scientist/Associate Director in Bioanalytical Sciences to lead the development and implementation of bioassays, provide scientific oversight, and ensure high-quality data delivery for drug development.

BiotechnologyHealth CarePharmaceuticalTherapeutics

Responsibilities

Provide leadership and represent the bioanalytical group on project teams, oversee assay development/validation/performance monitoring at CROs, and ensure on-time, high-quality delivery of data and reports supporting drug development

Coordinate CRO and vendor selection (e.g., quote, capability assessments, site audits), oversee contracts/SOWs process

Review and approve bioanalytical protocols, reports, and related documentation

Manage timelines for delivery of assays, data, and reports to support clinical studies and regulatory submissions

Ensure that work is completed with appropriate quality according to regulatory standards and guidelines

This person should be aware of the latest regulatory guidelines for bioanalytical assays

Develop and oversee execution of bioanalytical strategy to ensure the scientific quality of data meets regulatory and scientific requirements

Gain experience in developing exploratory biomarker assays

Opportunity to learn and develop appropriate laboratory manuals, prepare bioanalytical sections of regulatory documents, and respond to agency inquiries

Qualification

Bioanalytical method developmentBioanalytical assay validationRegulatory guidelines knowledgeImmunologyMolecular BiologyBiochemistryAnalytical platforms expertiseInterpersonal skillsLeadership skillsCommunication skillsTime-management skills

Required

PhD or M.S. degree in Immunology, Molecular Biology, Biochemistry, or related discipline with 4+ years of industry experience (6+ for M.S. degree) in bioanalytical method development, validation, and sample analysis in a regulated environment

Title commensurate with experience

Strong scientific background and in-depth technical expertise on the development, troubleshooting, and validation of bioanalytical assays for biological compounds (ELISA and MSD based)

Subject matter expert in analytical platforms

Experience developing and implementing PK, antidrug antibody, and neutralizing antibody assays for antibody-based therapeutics

Experience in successful development and execution of clinical bioanalytical assays implemented from early to late phase clinical programs

Current knowledge of regulatory guidelines related to qualification and validation of bioanalytical assays

Excellent interpersonal, leadership, communication, and time-management skills

Desire to work within a fast-paced, innovative, and collaborative environment