Stability Coordinator/Manager
Viking Therapeutics, Inc.
August 23, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Operations
Responsibilities:
- Plan, coordinate, and manage drug substance and drug product stability programs in support of the CMC pipeline, including phase-appropriate stability studies from early development through late-stage clinical/pre-commercial activities.
- Design and oversee ICH-compliant stability protocols; manage sample inventory and pull schedules.
- Author/review/maintain stability protocols, reports, specifications, and trend analyses.
- Track and trend stability data; lead/support OOS and OOT investigations with Analytical Development and Quality.
- Serve as primary point of contact for external CROs/CMOs/contract testing labs; manage sample logistics, chamber storage, timelines, and data deliverables.
- Establish and 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 support responses to agency questions with Regulatory Affairs.
- Maintain compliance with ICH stability guidance (Q1A–Q1F, Q5C) and cGMP; ensure data integrity (ALCOA+).
- Provide stability program updates and present risks/timelines to technical and executive stakeholders.
- Other duties as assigned.
Requirements:
- B.S. (4+ years) in Chemistry/Pharmaceutical Sciences/Biochemistry or related, or M.S. (2+ years), or Ph.D. with relevant experience.
- Hands-on experience managing ICH-compliant pharmaceutical stability studies (drug substance and/or drug product).
- Experience with CROs/CMOs/contract testing labs and outsourced stability testing.
- Working knowledge of ICH stability guidelines, cGMP, and CMC regulatory expectations (3.2.S.7 / 3.2.P.8).
- Experience with stability trending, OOS/OOT investigations, shelf-life/expiry determination, and stability-indicating analytical methods.
Preferred:
- Experience with peptide/GLP-1 or GIP agonist stability, degradation pathways, or cold-chain handling; familiarity with LIMS and ALCOA+ practices.
- Strong written/verbal communication; ability to translate data into reports/regulatory documents; entrepreneurial, highly organized mindset for managing multiple priorities.
Salary: $100,000–$125,000 annual salary.
- Plan, coordinate, and manage drug substance and drug product stability programs in support of the CMC pipeline, including phase-appropriate stability studies from early development through late-stage clinical/pre-commercial activities.
- Design and oversee ICH-compliant stability protocols; manage sample inventory and pull schedules.
- Author/review/maintain stability protocols, reports, specifications, and trend analyses.
- Track and trend stability data; lead/support OOS and OOT investigations with Analytical Development and Quality.
- Serve as primary point of contact for external CROs/CMOs/contract testing labs; manage sample logistics, chamber storage, timelines, and data deliverables.
- Establish and 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 support responses to agency questions with Regulatory Affairs.
- Maintain compliance with ICH stability guidance (Q1A–Q1F, Q5C) and cGMP; ensure data integrity (ALCOA+).
- Provide stability program updates and present risks/timelines to technical and executive stakeholders.
- Other duties as assigned.
Requirements:
- B.S. (4+ years) in Chemistry/Pharmaceutical Sciences/Biochemistry or related, or M.S. (2+ years), or Ph.D. with relevant experience.
- Hands-on experience managing ICH-compliant pharmaceutical stability studies (drug substance and/or drug product).
- Experience with CROs/CMOs/contract testing labs and outsourced stability testing.
- Working knowledge of ICH stability guidelines, cGMP, and CMC regulatory expectations (3.2.S.7 / 3.2.P.8).
- Experience with stability trending, OOS/OOT investigations, shelf-life/expiry determination, and stability-indicating analytical methods.
Preferred:
- Experience with peptide/GLP-1 or GIP agonist stability, degradation pathways, or cold-chain handling; familiarity with LIMS and ALCOA+ practices.
- Strong written/verbal communication; ability to translate data into reports/regulatory documents; entrepreneurial, highly organized mindset for managing multiple priorities.
Salary: $100,000–$125,000 annual salary.