Stability Scientist

About the role

The Stability Scientist joins Vantive’s Drug Products and Sciences R&D Stability team to apply chemistry and stability expertise across new and existing product projects. The role supports the establishment of shelf‑life, expiration dating, and regulatory compliance for vital organ therapy products.

Key responsibilities

• Represent R&D‑Stability on cross‑functional project teams to achieve project goals.
• Design and implement stability strategies for new product development, clinical trials, and sustaining projects.
• Create GMP‑compliant stability studies to establish expiration dating and support product labeling.
• Develop technical justifications for expiration dating and defend recommendations to business partners.
• Perform stability assessments for new products or product changes, ensuring appropriate methods and specifications.
• Identify risks, issues, and improvement opportunities in existing processes and technologies.
• Collaborate with manufacturing sites to gather test methods, specifications, and historical stability data.
• Act as study director for stability projects, conducting data trend analyses for new, modified, or sustaining products.

Required profile

• Demonstrated expertise in pharmaceutical stability planning and chemistry.
• Experience designing GMP stability studies and interpreting stability data.
• Ability to develop technical justifications and communicate scientific rationale to stakeholders.
• Strong analytical skills for risk identification and process improvement.

Required skills