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Evommune, Inc. is a clinical-stage biotechnology company headquartered in Palo Alto, California, focused on developing innovative therapies for immune-mediated inflammatory diseases. The company combines deep immunology expertise with disciplined clinical development to advance a differentiated pipeline addressing significant unmet medical needs.
This hybrid role is based in Palo Alto with an expectation of in-office presence two days per week and remote work flexibility up to three days per week, with occasional additional onsite time as needed for business priorities.
The Associate Director/Director of Analytical Development for Biologics will lead the analytical development strategy and execution for the company's biologic therapeutic programs. This position sits at the intersection of analytical chemistry, process development, and clinical manufacturing, requiring deep expertise in characterization, stability, and manufacturing analytics for monoclonal antibodies, proteins, or other biologics.
Key responsibilities include: directing the analytical development roadmap aligned with clinical and commercial timelines; leading cross-functional teams in analytical method development, validation, and transfer; ensuring regulatory compliance and quality by design principles; managing relationships with contract research organizations and manufacturing partners; and contributing to regulatory submissions and inspections.
The ideal candidate brings 10+ years of experience in analytical development for biologics, with demonstrated leadership in managing teams and complex projects. Strong technical foundation in analytical techniques (HPLC, mass spectrometry, electrophoresis, etc.), process analytical technology (PAT), and regulatory knowledge (ICH, FDA guidance) is essential. Experience in clinical-stage or early commercial biotech environments is highly valued, as is the ability to balance scientific rigor with operational pragmatism in a fast-moving organization.
