Stability Coordinator/Manager

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. This role partners closely with internal Analytical Development, Drug Substance, Drug Product, Quality, and Regulatory Affairs teams, as well as with external contract research organizations (CROs), contract manufacturing organizations (CMOs), and contract testing laboratories, to plan and execute phase-appropriate stability studies from early-stage development through late-stage clinical and pre-commercial activities. The Stability Coordinator / Manager will design and oversee ICH-compliant stability protocols, manage sample inventory and pull schedules, trend and interpret stability data, and support shelf-life and expiry determinations for small molecule and peptide-based products. The role will contribute stability data and sections to CMC documentation and regulatory submissions across Viking’s portfolio, including the company’s lead GLP-1/GIP dual agonist programs (VK2735) and additional metabolic and endocrine disorder pipeline assets. The level of the role will be commensurate with the candidate’s experience and qualifications.

Essential Duties and Responsibilities

The main responsibilities of this role include:

• Coordinate and manage drug substance and drug product stability programs under ICH storage conditions, including protocol design, sample pull schedules, and inventory across internal programs and outsourced testing laboratories.
• Author, review, and maintain stability protocols, reports, specifications, and trend analyses; ensure phase-appropriate stability strategies aligned with each program’s development stage.
• Track and trend stability data and lead or support out-of-specification (OOS) and out-of-trend (OOT) investigations in collaboration with Analytical Development and Quality.
• Serve as the primary point of contact for external CROs, CMOs, and contract testing laboratories for stability activities; manage sample logistics, chamber storage, timelines, and data deliverables for outsourced testing.
• Establish and justify shelf-life, retest, and expiry assignments based on stability data and applicable ICH guidelines.
• Contribute stability data and sections to CMC portions of INDs, CTAs, NDAs, and other regulatory filings (3.2.S.7 / 3.2.P.8); support responses to agency questions in collaboration with Regulatory Affairs.
• Maintain compliance with ICH stability guidelines (Q1A–Q1F, Q5C) and cGMP requirements; ensure sound GMP documentation practices and data integrity (ALCOA+).
• Partner cross-functionally with Drug Product, Drug Substance, Analytical Development, Quality, Supply Chain, and Regulatory to ensure integrated, on-time stability deliverables.
• Provide stability program updates at integrated project team meetings and present data trends, risks, and timelines to technical and executive stakeholders.
• Other duties as assigned.