Lead, Analytical Development – Oligonucleotide & Small Molecule

Denali Therapeutics Inc

South San Francisco (CA)

On-site

USD 159,000 - 207,000

Full time

3 days ago
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Benefits offered by this job

401k
Healthcare coverage
ESPP

Job summary

Denali Therapeutics Inc. is seeking a Lead for the Oligonucleotide & Small Molecule CMC Analytical Development team.

You will mentor staff, set day-to-day priorities, and lead method development, qualification, validation, transfer, testing and material characterization with a hands-on lab presence. Responsibilities include guiding cross-functional teams across discovery, process chemistry, formulation, quality, and regulatory, and coordinating CRO/CDMO activities to meet program goals and

Qualifications

  • Ph.D. in Analytical Chemistry, Chemistry, Pharmaceutical Sciences, or related discipline with 7+ years of industry experience, or MS/BS with extensive experience.
  • 5+ years hands-on analytical development experience for oligonucleotide and/or small-molecule products.
  • Strong leadership and mentoring ability to manage a small team.

Responsibilities

  • Lead and mentor the analytical development team, setting priorities and guiding data review.
  • Oversee method development, qualification, validation, transfer, and testing for oligonucleotide and small-molecule materials.

Skills

Oligonucleotide analysis
CMC Analytical Development
Leadership
Regulatory documentation

Education

Ph.D. in Analytical Chemistry or related field

Tools

HPLC/UPLC
Mass spectrometry
GC
DSC/TGA

Job description

Denali Therapeutics Inc. is seeking a Lead for the Oligonucleotide & Small Molecule CMC Analytical Development team.

You will mentor staff, set day-to-day priorities, and lead method development, qualification, validation, transfer, testing and material characterization with a hands-on lab presence. Responsibilities include guiding cross-functional teams across discovery, process chemistry, formulation, quality, and regulatory, and coordinating CRO/CDMO activities to meet program goals and

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