Lead Scientist, Protein Formulation & Drug Product

Denali-Therapeutics; South San Francisco (CA); On-site; USD 159,000 - 207,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics invites you to join our Formulation & Drug Product Development team as a Principal Scientist, leading formulation and DP development for a portfolio of protein biologics. You will work with analytical, bioprocess and QA to drive stability, compatibility, and comparability across development stages.

You will design studies, oversee DP characterization and validation, and author regulatory-ready documents while partnering with CMOs for tech transfer and manufacturing readiness.

Qualifications

• PhD with 10+ years of industry experience in formulation and drug product development for protein therapeutics.
• Deep hands-on experience with analytical protein characterization and biophysical methods.
• Experience transferring DP methods to CMOs and regulatory filings.

Responsibilities

• Independently drive formulation and drug product development for large molecule biotherapeutics.
• Design formulation studies, establish shelf life and in-use compatibility.
• Oversee DP process development, characterization, and validation for clinical/commercial use.
• Perform biophysical characterization and translate CQAs into robust formulations.
• Lead tech transfer, CMOs oversight, and regulatory documentation.

Skills

Formulation & DP development

Biotherapeutic stability

Cross-functional collaboration

Analytical characterization methods

Statistical data interpretation

Regulatory/CMC knowledge

Education

PhD in Chemical Engineering or Pharmaceutical Sciences or Biophysics or Analytical Chemistry

Tools

HPLC

LC-MS

cIEF

Capillary electrophoresis

SPR

Job description

Denali Therapeutics invites you to join our Formulation & Drug Product Development team as a Principal Scientist, leading formulation and DP development for a portfolio of protein biologics. You will work with analytical, bioprocess and QA to drive stability, compatibility, and comparability across development stages.

You will design studies, oversee DP characterization and validation, and author regulatory-ready documents while partnering with CMOs for tech transfer and manufacturing readiness.