Director, Biologics Analytical Development

Evommune, Inc.; Palo Alto (CA); Hybrid; USD 190,000 - 260,000; Full time

Job summary

Evommune, Inc. seeks an Associate Director / Director of Analytical Development to lead biologics analytics across our clinical pipeline.

You will oversee method development, transfer to CDMOs, qualification, validation, stability programs, reference standards, and data interpretation to support regulatory submissions. The role requires deep knowledge of biologics analytics, cGMP, and regulatory guidelines, with cross-functional collaboration across QA, Regulatory, and process development in a

Qualifications

• 8+ years of relevant industry experience with PhD, 10+ with MS, or 12+ with BS.
• Demonstrated experience in analytical method development, qualification, and validation for a broad range of assays.
• Experience overseeing analytical development at external labs and CDMOs.
• Thorough knowledge of FDA/EMA/ICH and GMP requirements for biologics analytics.

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.
• Coordinate analytical method transfers between external labs and CDMOs.
• Develop phase-appropriate method qualification and validation strategies.

Skills

Analytical method development

CDMO/vendor management

Regulatory submissions support

Biologics knowledge

Team leadership

Education

Biochemistry/Pharmaceutical Sciences/Analytical Chemistry degree (PhD/MS/BS as applicable)

Tools

Chromatography

Electrophoresis

Mass spectrometry

Binding assays

Potency assays

Cell-based assays

Job description

Evommune, Inc. seeks an Associate Director / Director of Analytical Development to lead biologics analytics across our clinical pipeline.

You will oversee method development, transfer to CDMOs, qualification, validation, stability programs, reference standards, and data interpretation to support regulatory submissions. The role requires deep knowledge of biologics analytics, cGMP, and regulatory guidelines, with cross-functional collaboration across QA, Regulatory, and process development in a