Oligonucleotide Analytics Lead — Method Development & QC

BioPhase

San Diego (CA)

On-site

USD 120,000 - 170,000

Full time

14 days+

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Job summary

BioPhase is seeking a Senior Scientist for the Analytical Development & Quality Control group. You will apply analytical chemistry to oligonucleotide therapeutics using QTOF-MS, LC-MS, HPLC, GC, and MALS in a GMP setting.

Independent, detail-oriented, and collaborative, you will advance method development, reference standard characterization, and regulatory submissions. Responsibilities include method validation, impurity profiling, investigation of OOS/OOT cases, and contributing to IND/NDA/MAA

Qualifications

Ph.D. in Analytical Chemistry or related field with 2+ years in industry; or M.S. with 8+ years.
Hands-on analytical development for oligonucleotide therapeutics (ASOs, siRNA or related modalities).
Advanced QTOF MS proficiency for oligonucleotide characterization and impurity profiling.
Expertise in ion-pair reversed-phase LC-MS for purity and impurity profiling.
GMP laboratory experience and knowledge of ICH guidelines.

Responsibilities

Develop and validate analytical methods for oligonucleotide drug substances and starting materials.
Characterize reference standards using UV, MS, NMR, and hyphenated LC techniques.
Conduct OOS and OOT investigations with root-cause analysis and CAPA development.
Author analytical method validation packages and contribute to CMC sections of regulatory filings.
Present findings at internal meetings and cross-functional teams.