Stability Program Manager — Pharma/Biotech

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

Job summary

Viking Therapeutics is seeking a Stability Coordinator/Manager to plan and oversee stability programs across its CMC pipeline, coordinating with Analytical Development, Drug Substance, Drug Product, Quality, and Regulatory Affairs. The role includes protocol design, data trend analysis, and regulatory support for INDs/NDAs, with collaboration across internal teams and CROs/CMOs.

The ideal candidate has 4+ years in pharmaceutical stability/analytical operations and a strong understanding of ICH

Qualifications

• BS in Chemistry or related field with 4+ years in stability/analytical operations.
• MS/PhD with relevant experience acceptable for senior level.
• Experience with ICH stability guidelines (Q1A-Q1F, Q5C) and cGMP.

Responsibilities

• Coordinate and manage stability programs for drug substances/products under ICH storage conditions.
• Author and maintain stability protocols, reports, and trend analyses.
• Track stability data, investigate OOS/OOT, and support regulatory filings (3.2.S.7 / 3.2.P.8).
• Serve as primary point of contact for CROs/CMOs for stability activities.
• Ensure data integrity and compliance with ALCOA+ standards.

Skills

Stability program management

Data trend analysis

Regulatory documentation

Cross-functional collaboration

Written and verbal communication

Education

BS in Chemistry/Pharmaceutical Sciences

MS/PhD in related field (optional)

Tools

LIMS

Regulatory submission tools

Job description

Viking Therapeutics is seeking a Stability Coordinator/Manager to plan and oversee stability programs across its CMC pipeline, coordinating with Analytical Development, Drug Substance, Drug Product, Quality, and Regulatory Affairs. The role includes protocol design, data trend analysis, and regulatory support for INDs/NDAs, with collaboration across internal teams and CROs/CMOs.

The ideal candidate has 4+ years in pharmaceutical stability/analytical operations and a strong understanding of ICH