Associate Director/ Director, Analytical Development, Biologics

Evommune, Inc.•Palo Alto, CA

4d•$190,000 - $260,000

About The Position

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.

Requirements

Degree in Biochemistry, Pharmaceutical Sciences, Analytical Chemistry or related field.
8+ years of relevant industry experience with PhD, 10+ years with MS, or 12+ years with BS.
Demonstrated experience in analytical method development, qualification, and validation for a broad range of assays, including cell-based assays for biologics
Experience with relevant biologics analytical platforms, such as chromatography, electrophoresis, mass spectrometry, binding assays, potency assays, and cell-based assays.
Strong ability to critically evaluate complex analytical data, identify trends and risks, and translate findings into clear technical recommendations.
Demonstrated experience overseeing analytical development activities at external laboratories and CDMOs, including technical review, issue resolution, timeline management, and vendor accountability.
Experience with lot release and stability testing of current Good Manufacturing Practice material.
Thorough knowledge of applicable FDA, EMA, ICH, and current Good Manufacturing Practice requirements governing biologics analytical development, validation, stability, comparability, specifications, and release testing.
Experience with monoclonal antibodies and fusion proteins
Strong technical judgment and ability to make phase-appropriate recommendations in a lean biotech environment
Demonstrated ability to influence cross-functional decisions and lead activities without direct authority.
For consideration at the Director level, demonstrated experience independently setting analytical strategy, influencing cross-functional program decisions, and representing analytical development in regulatory interactions is expected.

Nice To Haves

Experience in inflammatory or immunology programs
Experience preparing for and participating in regulatory meetings
Experience supporting programs through multiple stages of clinical development and significant manufacturing or process changes.
Experience supporting analytical comparability assessments and regulatory submissions across multiple geographic regions.

Responsibilities

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 translate findings into clear technical recommendations and program decisions.
Participate in external vendor, laboratory, and CDMO screening and selection.
Define technical scopes of work, deliverables, timelines, and performance expectations for external partners.
Manage external laboratories and CDMOs responsible for analytical development, method transfer, qualification, validation, release testing, and stability testing.
Coordinate with Quality Assurance to ensure compliance with current Good Manufacturing Practice requirements.
Review and approve key technical documents, including method procedures, development reports, qualification and validation protocols and reports, lot-release data and certificates of analysis, stability protocols and reports, deviations, investigations, and change controls.
Provide effective technical and operational oversight of external partners, including performance management, issue escalation, and resolution of timeline or quality risks.
Identify and troubleshoot complex technical issues with CDMOs and internal stakeholders.
Collaborate with process development and manufacturing teams to support clinical manufacturing, process characterization, investigations, and non-routine sample analysis.
Partner cross-functionally with other CMC team members, Quality Assurance, Regulatory, and Project Management to ensure execution of analytical deliverables within broader program plans.
Develop phase-appropriate analytical control strategies, specifications, and comparability plans in partnership with CMC leadership, Quality Assurance, Regulatory, and process development.
Identify analytical risks and proactively develop mitigation plans.
Represent analytical development in cross-functional program and CMC team discussions and provide clear recommendations regarding technical risks, options, and tradeoffs.
Author and review relevant CMC Module 3 content and provide analytical development input for INDs, amendments, briefing packages, responses to health authority questions, and other regulatory submissions across relevant territories.
Support preparation for and participation in regulatory meetings and interactions, as appropriate.
Partner with functional leads and Project Management to ensure analytical development timelines are aligned with broader program timelines.
Develop options and recommendations for resolving technical challenges, clearly communicating associated risks, tradeoffs, timelines, and resource implications.
Work with the Executive Director, CMC Biologics, to ensure timely access to appropriate resources for analytical development activities.
Support vendor planning, budget forecasting, contract management, and resource prioritization for analytical development activities.
Monitor external partner deliverables, budgets, and timelines and proactively communicate potential risks or changes to program plans.