Stability Program Manager

Aldevron - Madison, WI

Full-time

Madison, WI

Chemical Manufacturing

About the position

The position is part of the Stability Department at Aldevron, located in Fargo, ND, and involves ensuring regulatory compliance of stability programs. The role includes providing guidance for developmental stability programs, approving and developing stability strategies, and facilitating the execution of these strategies across various functional areas. The position requires strong analytical skills to interpret stability data and experience with software tools for data analysis.

Responsibilities

• Ensure regulatory compliance of Aldevron stability programs.
• Provide guidance and support to inter departments for developmental stability programs on new products, technical transfers, and change controls.
• Approve and develop stability strategies based on regulatory requirements, internal procedures, technical information, and historical stability data.
• Facilitate execution of the established stability strategy across functional areas and across internal and external sites.
• Manage stability study initiation, stability sample management, stability storage, and stability testing.
• Analyze and interpret stability data, including statistical analysis.

Requirements

• Extensive knowledge of stability testing protocols, methodologies, and regulatory requirements (e.g., ICH guidelines).
• Proficiency in analytical techniques such as HPLC, UV-Vis spectroscopy, and other relevant analytical methods.
• Familiarity with FDA, EMA, and other international regulatory bodies' requirements and guidelines for stability studies.
• Understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Documentation Practices (GDP).
• Strong ability to analyze and interpret stability data, including statistical analysis.

Nice-to-haves

• Experience in a stability testing or quality control role within the pharmaceutical, biotechnology, or related industry.
• Proven experience in managing stability studies from inception to conclusion, including protocol development, sample management, and reporting.
• Ability to work effectively in a team environment, collaborating with R&D, Quality Assurance, Regulatory Affairs, and other departments.