Director, Bioassay Development: Biologics Potency Lead

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

Benefits offered by this job

401k

Healthcare coverage

ESPP

Benefits

Job summary

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

You will guide potency and plate-based impurity assay programs across development stages, ensuring phase-appropriate rigor and regulatory alignment. The role requires deep expertise in biologics bioassays, assay transfer, and regulatory submissions, with a track record of leading scientists and delivering robust methods

Qualifications

• Typically requires a Ph.D. in biochemistry, molecular biology, cell biology, or a related discipline with 10+ years of directly relevant biotechnology or pharmaceutical industry, including 8+ years in a people leadership role.
• Deep technical expertise in bioassay development for protein biologics, including ligand-binding and cell-based potency methods and plate-based impurity assay formats.
• Hands-on experience developing potency assays for complex biologics such as recombinant proteins, enzymes, Fc-fusion proteins, monoclonal antibodies, bispecifics, receptor-targeted biologics, or other engineered protein therapeutics.
• Strong knowledge of assay statistics, design of experiments, reference standard strategy, assay trending, and troubleshooting of complex biological assays.
• Demonstrated experience with plate-based impurity assays, host cell protein ELISA, residual DNA, residual affinity ligands, process residuals, or product/process-specific impurities.
• Strong understanding of CMC development for biologics, including analytical control strategy, critical quality attributes, reference standards, method qualification, validation, transfer, comparability, stability, and specification setting.
• Experience supporting biologics programs across multiple development stages, ideally including early clinical development, late-stage development, regulatory filing, commercial launch, or post-approval lifecycle management.
• Prior experience managing experienced scientists and leading a functional or sub-functional team within Analytical Development, CMC, Technical Operations, or Quality Control.
• Strong working knowledge of GMP expectations and regulatory requirements for biologics analytical methods.
• Experience authoring or reviewing regulatory submission content and responding to regulatory questions related to analytical methods.
• Demonstrated ability to lead through ambiguity, prioritize across multiple programs, and make phase-appropriate technical decisions in a fast-moving biotech environment.

Responsibilities

• Lead the Bioassay Development sub-function within CMC Analytical Development, providing scientific, technical, and people leadership for potency methods and plate-based impurity assays supporting protein biologics across the development lifecycle.
• Develop and implement phase-appropriate bioassay strategies for programs spanning early development, clinical-stage advancement, late-stage readiness, and commercial lifecycle support, ensuring methods are fit for purpose at each stage.
• Drive development of robust, mechanism-of-action-based potency and plate-based impurity methods for complex biologics, including enzymatic activity, receptor binding, cellular uptake, signaling, functional cell-based assays, reporter assays, and other relevant biological readouts.
• Lead program-specific potency assay strategy and development, including assay design, development, optimization, qualification, validation, transfer, and lifecycle management in alignment with product mechanism of action, critical quality attributes, and regulatory expectations.
• Mentor, develop, and grow a high-performing team of scientists, providing technical guidance, career development, prioritization, feedback, and coaching.

Skills

Bioassay development

Potency assays

Assay statistics

Plate-based impurity assays

CMC development

Regulatory submissions

Team leadership

GMP knowledge

Regulatory questions

Ambiguity management

Education

Ph.D. in Biochemistry/Molecular Biology/Cell Biology

10+ years industrial biotech/pharma

MS + 14+ years experience

Job description

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

You will guide potency and plate-based impurity assay programs across development stages, ensuring phase-appropriate rigor and regulatory alignment. The role requires deep expertise in biologics bioassays, assay transfer, and regulatory submissions, with a track record of leading scientists and delivering robust methods