Stability Program Manager - Pharma/CMC

Scorpion Therapeutics; United States; On-site; USD 100,000 - 125,000; Full time

Job summary

Viking Therapeutics is seeking a Stability Coordinator/Manager to plan and manage stability programs across early development through late-stage clinical and pre-commercial activities. You will oversee protocol design, data trending, and regulatory filings, coordinate CRO/CMO testing, ensure ICH and cGMP compliance, and partner with cross-functional teams to deliver timely stability updates.

This role requires BS + 4+ years or MS/PhD in appropriate fields, with strong communication and data

Qualifications

• Hands-on experience managing stability programs under ICH guidelines.
• Experience coordinating outsourced stability testing with CROs/CMOs.
• Ability to deliver stability data for regulatory submissions.
• Strong knowledge of cGMP and ALCOA+ data integrity standards.
• Excellent written and verbal communication for regulatory documents.

Responsibilities

• Coordinate and manage stability programs under ICH storage conditions.
• Author/review stability protocols, reports, specifications, and trend analyses.
• Lead investigations (OOS/OOT) with Analytical Development and Quality.
• Serve as primary contact for CROs/CMOs and manage sample logistics.
• Establish shelf-life, retest, and expiry determinations per ICH guidelines.
• Contribute stability data to CMC sections of INDs/CTAs/NDAs and filings.
• Ensure compliance with ICH Q1A–Q1F, Q5C and cGMP; maintain data integrity.

Skills

ICH Guidelines

Stability Data Trending

Outsourced Stability Testing

cGMP & ALCOA+

Regulatory Documents

Communication Skills

Data Integrity

Education

Bachelor's in Chemistry

Master's in Related Field

PhD in Relevant Field

Tools

LIMS

Stability Data Systems

Job description

Viking Therapeutics is seeking a Stability Coordinator/Manager to plan and manage stability programs across early development through late-stage clinical and pre-commercial activities. You will oversee protocol design, data trending, and regulatory filings, coordinate CRO/CMO testing, ensure ICH and cGMP compliance, and partner with cross-functional teams to deliver timely stability updates.

This role requires BS + 4+ years or MS/PhD in appropriate fields, with strong communication and data