Stability Program Manager

Danaher - Fargo, ND

Full-time

Fargo, ND

Computer and Electronic Product Manufacturing

About the position

The Stability Program Manager at Aldevron plays a crucial role in ensuring the regulatory compliance of stability programs within the Quality Control Team. This position involves developing and approving stability strategies for new products, facilitating stability study execution, and providing guidance across departments. The role requires strong analytical skills to interpret stability data and ensure adherence to regulatory requirements.

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, including 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.