Senior Scientist, Oligonucleotide Analytics & QC (GMP)

BioPhase; San Diego (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

BioPhase is seeking a Senior Scientist to join the Analytical Development & Quality Control group. The role emphasizes analytical chemistry for oligonucleotide therapeutics, with hands-on expertise across QTOF-MS, LC-MS, HPLC, and GC in a GMP setting.

You will develop and validate methods for drug substances and starting materials, characterize reference standards, and contribute to regulatory submissions while working in a fast-paced, cross-functional environment.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field with 2+ years industry, or an M.S. with 8+ years.
• Hands-on analytical development for oligonucleotide therapeutics (ASOs, siRNA).
• Experience with QTOF mass spectrometry for oligonucleotide characterization and impurity profiling.
• Expertise in ion-pair reversed-phase LC-MS for oligonucleotide purity and impurities.

Responsibilities

• Develop and validate analytical methods for oligonucleotide drug substances, starting materials, and related impurities.
• Apply high-resolution QTOF mass spectrometry for accurate mass determination, sequence confirmation, and impurity profiling.
• Utilize MALS for molecular weight determination and aggregation characterization.
• Characterize reference standards using UV, MS, NMR, and hyphenated LC techniques.
• Conduct routine and non-routine analysis of raw materials and starting materials; review data for compliance.
• Design and execute analytical investigations including OOS and OOT with root cause analysis and CAPA.
• Author scientific reports, method validation packages, and contribute to CMC sections of regulatory filings.
• Write and revise SOPs, methods, and GMP-compliant procedures.
• Develop stability-indicating methods and contribute to stability programs.
• Present findings at internal meetings; contribute to publications and conference presentations.
• Serve as analytical SME on cross-functional teams spanning process development, manufacturing, and regulatory affairs.

Skills

Analytical development

Problem solving

Written and verbal communication

Cross-functional collaboration

Education

Ph.D. in Analytical Chemistry or related field

M.S. in Analytical Chemistry or related field

Tools

QTOF-MS

LC-MS

HPLC

GC

MALS

Job description

BioPhase is seeking a Senior Scientist to join the Analytical Development & Quality Control group. The role emphasizes analytical chemistry for oligonucleotide therapeutics, with hands-on expertise across QTOF-MS, LC-MS, HPLC, and GC in a GMP setting.

You will develop and validate methods for drug substances and starting materials, characterize reference standards, and contribute to regulatory submissions while working in a fast-paced, cross-functional environment.