Director, Biologics Analytical Development

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

Job summary

Evommune is seeking an Associate Director / Director, Analytical Development to lead biologics analytical development across the clinical pipeline. The role covers method development, transfer to CDMOs, qualification/validation, stability, reference standards, and data interpretation for regulatory submissions.

The candidate will manage external labs and CDMOs, ensuring phase-appropriate strategies align with cGMP and ICH guidelines in a fast-moving biotech environment.

Qualifications

• Degree in Biochemistry, Pharmaceutical Sciences, Analytical Chemistry or related field; 8+ years with PhD, 10+ with MS, or 12+ with BS.
• Experience with analytical method development, qualification, and validation for biologics.
• Experience with monoclonal antibodies and fusion proteins.
• Thorough knowledge of FDA, EMA, ICH, and GMP requirements governing biologics analytical development.
• Experience overseeing analytical development activities at external laboratories and CDMOs.
• Strong ability to translate complex analytical data into clear technical recommendations.

Responsibilities

• Lead phase-appropriate analytical development strategy for in-process control, release and stability testing.
• Oversee cell-based potency and other functional assay strategies for biologics.
• Design and implement stability studies and management of reference standards.
• Manage transfers of analytical methods between external labs and CDMOs.
• Define qualification/validation strategies and support regulatory submissions with analytical input.
• Provide technical oversight of external partners, timelines, and risk mitigation.

Skills

Analytical method development

Regulatory interactions

Cross-functional leadership

Vendor management

Biologics knowledge

Education

PhD in Biochemistry/Pharmaceutical Sciences/Analytical Chemistry

MS or BS in related field

Job description

Evommune is seeking an Associate Director / Director, Analytical Development to lead biologics analytical development across the clinical pipeline. The role covers method development, transfer to CDMOs, qualification/validation, stability, reference standards, and data interpretation for regulatory submissions.

The candidate will manage external labs and CDMOs, ensuring phase-appropriate strategies align with cGMP and ICH guidelines in a fast-moving biotech environment.