Lead, Analytical Development – Oligo & Small Molecule CMC

Denali Therapeutics; South San Francisco (CA); Vor Ort; USD 159.000 - 207.000; Vollzeit

Benefits dieser Stelle

401k

Healthcare coverage

ESPP

Zusammenfassung

Denali Therapeutics Inc. is a biotechnology company focused on delivering meaningful therapeutics across CNS diseases.

We seek a leader for the Oligonucleotide & Small Molecule CMC Analytical Development team to direct method development, testing, and characterization with hands-on lab leadership. You will oversee capabilities, external work, and regulatory documentation, collaborating across teams to meet program goals and timelines while maintaining data integrity and safety in a fast-paced

Qualifikationen

• PhD with 7+ years, or MS with 10+ years or BS with 12+ years in relevant industry.
• 5+ years hands-on analytical development supporting oligonucleotide and/or small-molecule drug substances and drug products.
• Demonstrated ability to lead and mentor a small team while balancing lab work and timely results.
• Deep expertise in chromatographic methods (HPLC/UPLC) and mass spectrometry; experience with GC, XRPD, DSC, TGA is desirable.
• Strong understanding of oligonucleotide synthesis, purification, impurity characterization, and analytical control strategies.
• Experience with method lifecycle activities, QC testing, stability programs, data integrity, and CMC regulatory expectations.
• Experience transferring analytical methods and providing oversight of CRO/CDMO activities.

Aufgaben

• Lead and mentor the analytical development team with hands-on involvement.
• Design, qualify, validate, transfer, test, and characterize analytical methods for oligonucleotide and small-molecule materials and products.
• Lead analytical activities for programs including impurity characterization and stability testing.
• Improve internal lab capabilities, instrumentation, data integrity, and safety.
• Analyze complex data and provide scientifically sound recommendations.
• Serve as the Analytical Development lead on cross-functional program teams.
• Plan and oversee work at CROs/CDMOs with technical guidance and data review.
• Prepare specifications, COAs, validation protocols, and regulatory CMC sections.

Kenntnisse

Analytical leadership

Chromatography (HPLC/UPLC)

Mass spectrometry

Laboratory management

Ausbildung

PhD in Analytical Chemistry

MS in Analytical Chemistry

BS in Chemistry

Tools

HPLC/UPLC

Mass spectrometry

GC

XRPD

Jobbeschreibung

Denali Therapeutics Inc. is a biotechnology company focused on delivering meaningful therapeutics across CNS diseases.

We seek a leader for the Oligonucleotide & Small Molecule CMC Analytical Development team to direct method development, testing, and characterization with hands-on lab leadership. You will oversee capabilities, external work, and regulatory documentation, collaborating across teams to meet program goals and timelines while maintaining data integrity and safety in a fast-paced