Biologics Analytical Development Leader

Jobless; Palo Alto (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Evommune seeks an Associate Director/Director, Analytical Development to lead strategy and execution for biologics programs across the clinical pipeline. You will oversee method development, transfers to CDMOs, qualification, validation, stability, reference standards, and data interpretation to support regulatory submissions.

The role requires directing external partners, navigating cGMP, and making phase-appropriate development decisions in a fast-moving biotech environment, with title

Qualifications

• Experience in analytical method development, qualification, and validation for a broad range of assays.
• Proven ability to oversee external labs and CDMOs with vendor accountability.
• Strong knowledge of FDA/EMA/ICH guidelines governing 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 assays for biologics.
• Design and execute stability studies and manage reference standards.
• Coordinate method transfers between external laboratories and CDMOs.
• Review technical documents and provide analytics input for regulatory submissions.
• Partner with QA, Regulatory, and Process Development to ensure compliant deliverables.

Skills

Analytical method development

Regulatory knowledge

Cross-functional leadership

Vendor management

Biologics analysis

Education

PhD in Biochemistry or related

MS in Biochemistry or related

BS in Biochemistry or related

Tools

Chromatography

Electrophoresis

Mass spectrometry

Binding assays

Potency assays

Cell-based assays

Job description

Evommune seeks an Associate Director/Director, Analytical Development to lead strategy and execution for biologics programs across the clinical pipeline. You will oversee method development, transfers to CDMOs, qualification, validation, stability, reference standards, and data interpretation to support regulatory submissions.

The role requires directing external partners, navigating cGMP, and making phase-appropriate development decisions in a fast-moving biotech environment, with title