Principal Scientist, Formulation & Drug Product Development

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

Job summary

Denali is seeking a Principal Scientist to lead formulation and drug product process development for its protein biologics portfolio in California. You will drive formulation studies, understand degradation mechanisms, and support scale-up and validation.

The role requires a PhD with 10+ years in protein therapeutics formulation, hands-on analytical characterization, and strong regulatory and CMO transfer experience. Collaboration across discovery, analytics, bioprocess, and quality is essential.

Qualifications

• PhD in a relevant field with 10+ years in protein therapeutics formulation.
• Hands-on expertise in analytical protein characterization, biophysical methods, high concentration formulations, and process validation.
• Strong statistical and analytical skills.
• Proven success in CMO tech transfer and regulatory support.
• Experience with prefilled syringes, combination devices, GMP compliance, and cross-functional collaboration.
• Work in biologics, formulation development, CMC, GMP, regulatory filings at early to later stages.

Responsibilities

• Independently drive formulation activities.
• Understand degradation mechanisms.
• Design formulation studies.
• Support process scale-up and validation.
• Perform biophysical characterization using chromatography and spectroscopy.
• Translate critical quality attributes into stable formulations.
• Author technical regulatory documents.
• Oversee CMO manufacturing and troubleshooting.
• Collaborate cross-functionally with discovery, analytical, bioprocess, and quality teams.

Skills

Analytical protein characterization

Biophysical methods

High concentration formulations

Process validation

Statistical analysis

Regulatory support

Education

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

Job description

Role: Principal Scientist leading formulation and drug product process development for Denali's protein biologics portfolio.

Responsibilities:

• independently drive formulation activities
• understand degradation mechanisms
• design formulation studies
• support process scale-up and validation
• perform biophysical characterization using chromatography and spectroscopy
• translate critical quality attributes into stable formulations
• author technical regulatory documents
• oversee CMO manufacturing and troubleshooting
• and collaborate cross-functionally with discovery, analytical, bioprocess, and quality teams

Requirements:

• PhD in Chemical Engineering, Pharmaceutical Sciences, Biophysics, or Analytical Chemistry with 10+ years industry experience in protein therapeutics formulation
• hands‑on expertise in analytical protein characterization, biophysical methods, high concentration formulations, and process validation
• strong statistical and analytical skills
• proven success in CMO tech transfer and regulatory support

Preferred:

• experience with prefilled syringes, combination devices, GMP compliance, and cross‑functional collaboration

High-Value:

biologics (protein therapeutics), formulation development, CMC, GMP, regulatory filings, at early clinical or later stages.

WorkSetup:

not specified; salary range $159K-$207K.