Senior Scientist, Analytical Development and Quality Control - Early Phase

Scorpion Therapeutics; Brisbane (CA); On-site; USD 162,000 - 186,000; Full time

Job summary

Scorpion Therapeutics is seeking an experienced Senior Scientist to lead DP analytical method development, validation, and lifecycle management for ASD and lipid-based formulations. You will support regulatory submissions and coordinate CDMO oversight to ensure compliance and timely delivery.

The role requires an advanced degree in chemistry/pharmaceutics or equivalent, with 8+ years (PhD) or 14+ years (BS/MS) industrial CMC experience, strong technical writing, and cross-functional

Qualifications

• Advanced degree in Chemistry, Pharmaceutics, or related field.
• Senior Scientist: BS/MS with 14+ years or PhD with 8+ years industrial CMC experience.
• Strong DP analytical development/validation experience; expertise with ASDs and/or lipid-based formulations.
• CDMO/contract testing lab oversight experience.
• Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings.
• ICH, cGMP, and pharmacopeial chapter fluency; cross-functional collaboration.
• Strong technical writing and ability to manage multiple priorities.

Responsibilities

• Lead DP analytical method development, validation, and lifecycle management for ASDs and lipid-based formulations.
• Support PPQ, commercialization, commercial QC, and lifecycle management for analytical methods and control strategies.
• Design/oversee DP development, registration batch, and commercial stability programs (protocols, trend analysis).
• Author/review DP analytical development reports to support IND/IMPD/NDA submissions and marketing authorization.
• Oversee analytical activities (method development, validation, QC testing) at CDMOs and CTLs.
• Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs.
• Critically review analytical data, protocols, reports, specifications, and documentation.
• Trend stability data; support retest periods and shelf-life using statistical methods.
• Collaborate on material control strategies and specifications.
• Author technical documentation (validation/stability protocols/reports, specifications, COAs, storage statements) and health authority responses.
• Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP/SOPs. Travel up to 5% as required.

Skills

DP analytical development

Validation

ASDs

lipid-based formulations

Regulatory submissions

CDMO oversight

Technical writing

Cross-functional collaboration

Education

Advanced degree in Chemistry/Pharmaceutics

Tools

IND/IMPD/NDA submissions

Job description

Responsibilities:

• Lead DP analytical method development, validation, and lifecycle management for ASDs and lipid-based formulations.


• Support PPQ, commercialization, commercial QC, and lifecycle management for analytical methods and control strategies.


• Design/oversee DP development, registration batch, and commercial stability programs (protocols, trend analysis).


• Author/review DP analytical development reports to support IND/IMPD/NDA submissions and marketing authorization.


• Oversee analytical activities (method development, validation, QC testing) at CDMOs and CTLs.


• Contribute to investigations (OOS/OOE/OOT), root cause analysis, and CAPAs.


• Critically review analytical data, protocols, reports, specifications, and documentation.


• Trend stability data; support retest periods and shelf-life using statistical methods.


• Collaborate on material control strategies and specifications.


• Author technical documentation (validation/stability protocols/reports, specifications, COAs, storage statements) and health authority responses.


• Maintain analytical documentation for traceability, data integrity, and inspection readiness; follow cGMP/SOPs. Travel up to 5% as required.

Qualifications:

• Advanced degree in Chemistry, Pharmaceutics, or related field.


• Senior Scientist: BS/MS with 14+ years or PhD with 8+ years industrial CMC experience.


• Strong DP analytical development/validation experience; expertise with ASDs and/or lipid-based formulations.


• CDMO/contract testing lab oversight experience.


• Experience supporting regulatory submissions (IND/IMPD/NDA) and global filings.


• ICH, cGMP, and pharmacopeial chapter fluency; cross-functional collaboration.


• Strong technical writing and ability to manage multiple priorities.

Salary Range: $162K–$186K