Job Description
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 Bio’s 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 & Leadership
- Lead the design, implementation, and oversight of integrated analytical strategies for verekitug across all stages of the product lifecycle through commercialization
- Provide 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 practices
- Develop stability strategies in accordance with regulatory guidelines and health authority expectations for biologics/combination products to generate data supporting shelf life
- Stay abreast of emerging analytical technologies and regulatory expectations, incorporating them into company strategies as appropriate.
Method Development & Validation
- Oversee 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 Support
- Establish 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 standards
- Drive cross-functional collaboration among Technical Operations, Quality, and Regulatory teams to ensure alignment of analytical strategies and timelines for the program
- Translate complex scientific data into cross-disciplinary insights to support decision making in regulatory submissions, technology transfer, and commercialization activities
- Champion 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 topics
Team Leadership & Management
- Build, 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 & Compliance
- Ensure 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 teams
About 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 verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. Learn more about us at upstreambio.com.