Stability Program Manager

Stability Manager

Job Description:
Seeking a highly motivated and detail-oriented Stability Manager to join a growing team. As a Stability Manager, you will be responsible for overseeing and managing the stability program as well as a team. This includes designing stability protocols, managing stability studies, analyzing data, and ensuring regulatory compliance. You will work closely with cross-functional teams, including production, quality control, and regulatory affairs, to ensure the timely and efficient execution of stability testing and reporting.

Key Responsibilities:

• Develop and implement stability protocols for new and existing products.
• Coordinate and manage stability studies, including storage conditions and sampling schedules.
• Analyze and interpret stability data to ensure product quality and compliance with regulatory standards.
• Prepare stability reports and present findings to internal teams and regulatory bodies.
• Collaborate with R&D, quality assurance, and manufacturing teams to address stability-related issues.
• Ensure adherence to GMP and regulatory requirements for stability testing.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field.
• 5+ years of experience in stability testing and regulatory compliance in a CDMO or pharmaceutical setting.
• Strong knowledge of ICH guidelines and GMP standards.
• Excellent communication and project management skills.