Stability Coordinator/Manager
Viking Therapeutics, Inc.
August 25, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
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.
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.