Principal Scientist/Associate Director, Bioanalytical Sciences

Position Summary:

The translational Sciences group at Upstream Bio is looking for a Principal Scientist/Associate Director, Bioanalytical Sciences who will lead the development and implementation of critical bioassays to support development programs and provide scientific and operational oversight of bioanalytical sample analyses.

You will represent the Bioanalytical function on cross-functional project teams. In partnership with project teams, you will provide bioanalytical scientific and operational leadership to drive robust and timely decision-making through all stages of clinical development.

Key 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.

If interested, the position will provide an opportunity to:

• 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.

Qualifications:

• 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.
• Knowledge and experience with budgeting and resource allocation is preferred.
• Excellent interpersonal, leadership, communication, and time-management skills.
• Desire to work within a fast-paced, innovative, and collaborative environment.

About Upstream Bio:

Upstream Bio is a public company based in Waltham, MA.

We are a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. We are developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. Upstream Bio has advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma and chronic obstructive pulmonary disease (COPD). Our team is committed to maximizing verekitug's unique attributes to address the substantial unmet needs for patients underserved by today's standard of care. To learn more, please visit
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*Base Compensation for this role will depend on a number of factors including a candidate's qualifications, skills, competencies, and experience. Base pay is only one component of the company's total rewards package. All regular employees are also eligible for the corporate bonus program or the incentive compensation program (if applicable), as well as equity. Additional benefits include health care, vision, dental, retirement, PTO, etc.