Stability Programs Manager

Viking Therapeutics, Inc.; San Diego (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Viking Therapeutics, Inc. is seeking a Stability Coordinator/Manager to plan, coordinate, and manage stability programs across the CMC pipeline, partnering with Analytical Development, Drug Substance/Product, Quality, and Regulatory Affairs teams.

The role involves designing ICH-compliant stability protocols, managing sample pull schedules, and contributing data for regulatory submissions, with collaboration across CROs, CMOs, and testing labs.

Qualifications

• Experience designing and executing ICH-stability studies.
• Ability to manage stability programs for drug substance/product.
• Experience coordinating with CROs/CMOs and external labs.

Responsibilities

• Coordinate stability programs under ICH storage conditions and manage sample inventory.
• Author and maintain stability protocols and reports; trend analyses.
• Lead or support OOS/OOT investigations with cross-functional teams.
• Serve as primary contact for external testing labs for stability activities.
• Determine shelf-life, retest, and expiry assignments per ICH guidelines.
• Contribute stability data to CMC sections of regulatory filings (INDs/CTAs/NDAs).
• Maintain ICH stability guideline and cGMP compliance; ensure data integrity (ALCOA).
• Present data trends and timelines to stakeholders.

Skills

ICH stability knowledge

Stability data trending

OOS/OOT investigations

Regulatory submissions support

Education

B.S. in Chemistry/Pharmaceutical Sciences/Biochemistry

M.S. or Ph.D. in related field (advantage)

Tools

LIMS

cGMP documentation

Job description

Viking Therapeutics, Inc. is seeking a Stability Coordinator/Manager to plan, coordinate, and manage stability programs across the CMC pipeline, partnering with Analytical Development, Drug Substance/Product, Quality, and Regulatory Affairs teams.

The role involves designing ICH-compliant stability protocols, managing sample pull schedules, and contributing data for regulatory submissions, with collaboration across CROs, CMOs, and testing labs.