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Stability Program Manager - PR/522843_1739340214

Expired

Stability Program Manager

Fargo
Permanent
Negotiable
Quality
PR/522843_1739340214
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.

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