Upstream Bio
Principal Scientist/Associate Director, Bioanalytical Sciences
Upstream Bio, Waltham, Massachusetts, United States, 02254
Overview
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
Develop and oversee execution of bioanalytical strategy to ensure the scientific quality of data meets regulatory and scientific requirements. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Science
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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
Develop and oversee execution of bioanalytical strategy to ensure the scientific quality of data meets regulatory and scientific requirements. 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. Seniority level
Mid-Senior level Employment type
Full-time Job function
Science
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