Senior Director of Analytical Development (Waltham)

Position Summary:The Senior Director of Analytical Development will be responsible for providing strategic, scientific, and operational leadership for the development, qualification, validation, and lifecycle management of analytical methods supporting Upstream Bios lead program verekitug. The Senior Director will report to Technical Operations leadership and serve as a key partner to Quality, CMC, Regulatory, and cross-functional teams. This individual will provide technical guidance and business acumen to ensure flawless execution of analytical activities for late-stage programs through BLA/MAA submission, approval, and commercial launch as well as lead, build, and mentor a team of high-performing individuals.Key Responsibilities:Analytical Strategy & LeadershipLead the design, implementation, and oversight of integrated analytical strategies for verekitug across all stages of the product lifecycle through commercializationProvide scientific and strategic leadership in the physicochemical and functional characterization of complex biologics, including the execution of comparability assessments and the development of a risk-based control strategy in alignment with ICH Q6B and Q5E.Design and oversee the strategic planning, qualification, lifecycle management, and operational execution of reference standards in accordance with regulatory requirements and industry best practicesDevelop stability strategies in accordance with regulatory guidelines and health authority expectations for biologics/combination products to generate data supporting shelf lifeStay abreast of emerging analytical technologies and regulatory expectations, incorporating them into company strategies as appropriate.Method Development & ValidationOversee the development, qualification, validation, and transfer of analytical methods (e.g., HPLC, CE, LC-MS, ELISA, binding assays, potency assays) in support of process development, release, and stability testing.Ensure analytical documentation and data packages comply with global regulatory requirements, including ICH guidelines, to support regulatory submissions and facilitate product approval globally.Collaboration & Cross-functional SupportEstablish comprehensive technical strategies and assume primary responsibility for the authoring and scientific justification of analytical sections within CMC regulatory submissions, ensuring compliance with appropriate regulatory standardsDrive cross-functional collaboration among Technical Operations, Quality, and Regulatory teams to ensure alignment of analytical strategies and timelines for the programTranslate complex scientific data into cross-disciplinary insights to support decision making in regulatory submissions, technology transfer, and commercialization activitiesChampion a culture of collaboration and transparency across disciplines to enable seamless progression through key development milestones.Serve as a subject matter expert (SME) during regulatory interactions, inspections, and due diligence activities related to analytical topicsTeam Leadership & ManagementBuild, mentor, and lead a high-performing analytical development team.Facilitate alignment between internal stakeholders and external partners (e.g. CDMOs, CROs) to ensure consistent execution of development plans and resolution of technical challenges.Data Integrity & ComplianceEnsure GLP/GMP compliance requirements and maintain data integrity standards.Drive continuous improvement and innovation within the analytical function.Qualifications:Advanced degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.12+ years of biotechnology or biopharmaceutical industry experience with a focus on analytical development for monoclonal antibodies or other complex biologics.Proven expertise in a broad range of analytical methodologies relevant to protein therapeutics.Strong knowledge of global regulatory requirements and expectations for biologics (ICH Q2, Q6B, USP, EMA, FDA). Experience authoring CMC sections of BLA/MAA is not required but strongly preferred.Experience managing external partners (CROs/CDMOs).Excellent organizational, leadership, and communication skills with a proven ability to influence cross-functional teamsAbout Upstream Bio: Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitugs unique attributes to address the substantial unmet needs for patients underserved by todays standard of care. Learn more about us at .

Created: 2025-09-24