Principal Scientist, Protein Formulation & DP Development

Denali Therapeutics Inc

South San Francisco (CA)

On-site

USD 159,000 - 207,000

Full time

4 days ago

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Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics Inc in South San Francisco, CA, seeks a Principal Scientist to lead formulation and drug product development for a growing portfolio of protein biologics. You will design studies, establish shelf life, and support comparability across development stages.

The role requires a PhD with 10+ years in DP/CMC for protein therapeutics, strong analytical skills, and hands-on LC-MS, HPLC, and cIEF experience. Collaboration with CMOs, QA, and other R&D teams is essential.

Qualifications

Typically a PhD in Chemical Engineering, Pharmaceutical Sciences, Biophysics, Analytical Chemistry or related field with 10+ years in formulation/DP development for protein therapeutics.
Extensive hands-on experience with analytical protein characterization and biophysical methods (HPLC-based, cIEF, CE, LC-MS, peptide mapping, spectroscopy, SPR, light scattering).
Experience with high concentration liquid formulation development and DP process transfer to CMOs; GMP familiarity.

Responsibilities

Lead formulation and DP development for large molecule biologics across development stages.
Design studies to establish shelf life, in-use compatibility, and comparability; develop stress comparability strategies.
Oversee DP process characterization and DP tech transfer to CMOs; review stability protocols and analytical method transfer.