Stability Coordinator/Manager

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

The Stability Coordinator / Manager is responsible for planning, coordinating, and managing drug substance and drug product stability programs in support of Viking Therapeutics’ CMC pipeline, including phase-appropriate ICH stability studies from early development through late-stage clinical and pre-commercial activities.

Essential Duties and Responsibilities:

• Coordinate and manage stability programs under ICH storage conditions (protocol design, sample pull schedules, inventory across internal and outsourced labs).
• Author/review/maintain stability protocols, reports, specifications, and trend analyses; align strategies to development stage.
• Track and trend stability data; lead/support OOS and OOT investigations with Analytical Development and Quality.
• Serve as primary contact for external CROs, CMOs, and contract testing labs; manage sample logistics, storage, timelines, and deliverables.
• Establish/justify shelf-life, retest, and expiry assignments based on stability data and ICH guidelines.
• Contribute stability data/sections to CMC portions of INDs, CTAs, NDAs and other regulatory filings (3.2.S.7 / 3.2.P.8); support agency question responses with Regulatory Affairs.
• Ensure compliance with ICH stability guidelines (Q1A–Q1F, Q5C), cGMP, GMP documentation, and ALCOA+ data integrity.
• Partner cross-functionally to deliver stability updates on time; present trends, risks, and timelines.

Requirements:

• B.S. (Chemistry/Pharmaceutical Sciences/Biochemistry or related) + 4+ years stability/analytical operations experience; or M.S. + 2+ years; or Ph.D. with relevant experience.

Knowledge and Skills:

• Hands-on experience managing stability programs (design, execution, data review).
• Experience managing outsourced stability testing (CROs/CMOs/labs) on time and within budget.
• Knowledge of ICH (Q1A–Q1F, Q5C), cGMP, and stability data expectations for CMC submissions (3.2.S.7 / 3.2.P.8).
• Stability data trending, OOS/OOT investigations, shelf-life/expiry determinations, stability-indicating methods.
• Plus: peptide or GLP-1/GIP stability/degradation/cold-chain experience; familiarity with stability data management systems/LIMS and ALCOA+.
• Strong written/verbal communication; ability to translate data into regulatory documents.
• Entrepreneurial, fast-paced environment; strong organization and multitasking.

Compensation:

$100,000.00–$125,000.00 annual salary.