Biologics Analytical Development Director

Amplitude Venture Capital; Palo Alto (CA); Hybrid; USD 190,000 - 260,000; Full time

Benefits offered by this job

Health, dental & vision plans

Pet insurance

401(k) plan

Paid parental leave

Life and disability insurance

Employee referral bonus

Job summary

Evommune, Inc. is seeking an Associate Director / Director of Analytical Development to lead the analytical strategy for biologics across the clinical-stage pipeline.

This role oversees method development, transfer to contract labs, qualification, validation, stability programs, reference standards, and data interpretation to support regulatory submissions. Ideal candidate will manage external laboratories and CDMOs, ensuring phase-appropriate development aligned with cGMP and regulatory

Qualifications

• 8+ years with PhD, 10+ years with MS, or 12+ years with BS.
• Experience in analytical method development, qualification, and validation for a broad range of assays.
• Thorough knowledge of FDA/EMA/ICH and cGMP requirements governing biologics analytics.

Responsibilities

• Lead phase-appropriate analytical development for in-process control, characterization, release and stability testing.
• Develop 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 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 investigations and data-driven program decisions.

Skills

Analytical method development

Biologics

External vendor management

Regulatory knowledge

Cross-functional collaboration

Project management

Education

PhD in Biochemistry

MS in Analytical Chemistry

BS in related field

Tools

Chromatography

Mass spectrometry

HPLC

CDMO management

Job description

Evommune, Inc. is seeking an Associate Director / Director of Analytical Development to lead the analytical strategy for biologics across the clinical-stage pipeline.

This role oversees method development, transfer to contract labs, qualification, validation, stability programs, reference standards, and data interpretation to support regulatory submissions. Ideal candidate will manage external laboratories and CDMOs, ensuring phase-appropriate development aligned with cGMP and regulatory