Associate Director​/ Director, Analytical Development, Biologics

About Evommune, Inc.

Evommune, Inc. (NYSE: EVMN) is a clinical-stage biotechnology company focused on developing innovative therapies for immune-mediated inflammatory diseases. Headquartered in Palo Alto, California, with additional operations in New York, NY, Evommune is advancing a differentiated pipeline designed to address the underlying drivers of disease.

Our scientific approach integrates deep immunology expertise with disciplined clinical development to deliver potentially best-in-class therapies for patients with significant unmet medical need. For more information, visit  .

Work Location: This hybrid position is currently expected to be in the office two days per week, with the option to work remotely up to three days per week. Occasional additional onsite presence may be required based on business needs or operational priorities.

Our Core Values

Before we dive into the specifics of the role, it's important to highlight the core values that are integral to being a member of the Evommune team. Our values are not just words; they shape our culture, guide our decision-making, and define what it means to be part of our team.

• Together We Win :
  We champion teamwork, celebrating every achievement as a shared success.
• Guided by Insight :
  We make data-driven decisions, using our collective experience to shape the future of our business.
• Every Day Matters :
  We act with urgency to bring transformative therapies to patients by being nimble, decisive, and effective.
• Driven By Excellence :
  We set a high bar and hold ourselves accountable to deliver exceptional results in everything we do.
• Empowered To Act :
  We invest in our team and value transparency, fostering trust and a sense of ownership.

We seek individuals who resonate with these principles, as they are essential for thriving in our collaborative, innovative, and dynamic work environment.

The Position

Associate Director / Director, Analytical Development

Evommune is seeking an Associate Director / Director, Analytical Development to lead analytical development strategy and execution for biologic therapeutic programs across our clinical-stage pipeline. This individual will be responsible for all aspects of biologics analytical development, including oversight of method development and transfer at contract labs, method qualification and validation, stability programs, reference standard management, data interpretation, and analytical support for regulatory submissions.

They will accomplish these activities by managing external development laboratories and contract manufacturers. The successful candidate must be able to make phase-appropriate development-related recommendations based on a thorough knowledge of principles of biologics analytical method development and validation, cGMP requirements, and regulatory/ICH guidelines.

The ability to operate effectively in a fast-moving, resource-disciplined biotech environment is essential for the successful candidate.

The final title will be determined based on the candidate’s experience, technical depth, strategic leadership capabilities, and demonstrated ability to independently lead analytical development activities across programs.

Key Responsibilities

Subject Matter Expertise

• Lead phase-appropriate analytical development for in-process control, characterization, release and stability testing.
• Develop and oversee cell-based potency and other functional assay strategies for biologics.
• Design and execute stability studies
• Manage the lifecycle of reference standards
• Manage analytical method transfers between external laboratories and CDMOs.
• Develop phase-appropriate method qualification and validation strategies.
• Develop strategies for extended characterization, comparability, and process-change assessments for biologics.
• Develop and justify phase-appropriate specifications and acceptance criteria for drug substance, drug product, reference standards, and stability programs.
• Lead or provide analytical subject matter expertise for out-of-specification, out-of-trend, deviation, and laboratory investigations. Critically evaluate complex analytical data and…