Senior Scientist / Assistant Director, Analytical Development and Quality Control

Job overview

The Senior Scientist / Assistant Director, Analytical Development and Quality Control role is onsite in San Diego, CA. The listed annual salary is $120,000–$180,000. The position is part of the Analytical Development and Quality Control group and supports oligonucleotide therapeutics development and regulatory submissions. The scientist develops and validates analytical methods, characterizes drug substances and reference standards, investigates analytical results, and contributes to regulatory documentation in a GMP environment. The work supports product quality, stability assessment, and cross-functional development and manufacturing activities.

What you'll do

• Develop and validate analytical methods for oligonucleotide drug substances, starting materials, and impurities
• use QTOF-MS, LC-MS, HPLC, GC, and MALS
• characterize reference standards
• analyze raw materials and review data against specifications
• conduct OOS and OOT investigations and develop CAPAs
• author reports, validation packages, and CMC filing sections
• write and revise GMP procedures and specifications
• support stability programs
• present findings and serve as an analytical subject matter expert.

What we're looking for

Skills & competencies

senior scientist

assistant director

analytical development

quality control

oligonucleotide therapeutics

qtof-ms

lc-ms

gmp

cmc regulatory submissions

san diego ca

biophase solutions

$120,000–$180,000 yearly

Work arrangement

• Weekend coverage required

Why this role

Requires hands-on analytical development experience with oligonucleotide therapeutics and advanced QTOF mass spectrometry expertise.

About the employer

BioPhase Solutions is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.