Senior Scientist, Analytical Development & QC – On-Site Newark

Protagonist Therapeutics; Newark (CA); On-site; USD 140,000 - 160,000; Full time

Benefits offered by this job

Health care benefits

401(k) Plan

Flexible vacation policy

Life Insurance

Short/Long-term disability

Lunch and snacks

Job summary

Protagonist Therapeutics is seeking a talented Senior Scientist to join the Analytical Development & Quality Control (ADQC) group in Newark, CA. The role drives analytical development strategies for small molecules and peptides, including method development, validation, transfer, and stability programs for DS and DP.

You will lead internal activities and manage CDMO partnerships to achieve program objectives.

Qualifications

• PhD or MS in Analytical Chemistry or a relevant scientific discipline with 5+ years in CMC development.
• Experience developing analytical methods for peptides or complex drug substances.
• Strong experience managing analytical development and QC functions at CDMOs.
• Proven ability to lead projects, communicate with stakeholders, and meet timelines.

Responsibilities

• Develop, optimize, and validate methods for release, stability, and characterization of DS/DP.
• Lead impurity identification, degradant analysis, method transfer, and lifecycle management.
• Establish robust analytical control strategies for clinical and regulatory needs.
• Triage OOS/OOT events, deviations, CAPA, and change control.
• Manage stability and reference standards programs; liaise with CDMOs.
• Prepare regulatory filings sections and support Module 3 inputs.
• Drive continuous improvement in processes and CDMO management.
• Represent ADQC in cross-functional team meetings.

Skills

UHPLC method development

Analytical method validation

CDMO management

Regulatory awareness

Cross-functional collaboration

Team leadership

Education

PhD or MS in Analytical Chemistry

Tools

UHPLC

MS

cGMP/GLP

Job description

Protagonist Therapeutics is seeking a talented Senior Scientist to join the Analytical Development & Quality Control (ADQC) group in Newark, CA. The role drives analytical development strategies for small molecules and peptides, including method development, validation, transfer, and stability programs for DS and DP.

You will lead internal activities and manage CDMO partnerships to achieve program objectives.