Director, Bioassay Development — Biologics Potency

Denali Therapeutics Inc; South San Francisco (CA); On-site; USD 208,000 - 271,000; Full time

Job summary

Denali Therapeutics Inc. seeks a Director, Bioassay Development to lead the Bioassay Development function within the Technical Operations Analytical & Formulation Development organization.

This leader will provide strategic leadership to a team responsible for potency assay development and plate-based impurity assay development for complex protein biologics across a pipeline spanning early clinical development through commercial lifecycle management.

Qualifications

• PhD in biochemistry, molecular biology, cell biology, or related field with 10+ years in biotech/pharma, including 8+ years in leadership.
• Deep expertise in bioassay development for protein biologics, including potency methods and plate-based impurity assays.
• Hands-on experience with complex biologics (recombinant proteins, antibodies, Fc-fusion, bispecifics).
• Strong knowledge of assay statistics, DOE, reference standards, and validation/transfer.
• Experience with GMP, regulatory submissions, and cross-functional collaboration.

Responsibilities

• Lead the Bioassay Development sub-function within CMC Analytical Development.
• Develop phase-appropriate bioassay strategies across development stages from early to commercial.
• Drive robust potency and impurity methods for complex biologics including cellular readouts.
• Lead program-specific potency strategy and lifecycle management for multiple programs.
• Mentor and grow a high-performing team of scientists and ensure training/compliance.
• Collaborate with Process Development, QC, QA, Regulatory CMC, Translational Sciences, and external partners.
• Establish assay control strategies, references, and statistical trending for lifecycle monitoring.
• Provide technical leadership for method transfer, troubleshooting, and regulatory support.

Skills

Bioassay development

Potency assay development

Plate-based impurity assays

Leadership/mentoring

Regulatory readiness

Education

PhD in biochemistry/molecular biology/cell biology or related

Tools

GMP

Regulatory submissions

Job description

Denali Therapeutics Inc. seeks a Director, Bioassay Development to lead the Bioassay Development function within the Technical Operations Analytical & Formulation Development organization.

This leader will provide strategic leadership to a team responsible for potency assay development and plate-based impurity assay development for complex protein biologics across a pipeline spanning early clinical development through commercial lifecycle management.