Stability Scientist

New Brunswick, New Jersey

Exciting Opportunity: Stability Scientist Wanted!

Join our dynamic pharmaceutical team dedicated to improving patient health through innovative drug development. We are committed to excellence and seek individuals who share our passion for delivering high-quality products

Job Summary:
Are you ready to take on a pivotal role in leading a stable product strategy? As a Stability Scientist, you will oversee stability programs for our small molecules Drug Substances and Drug Products, ensuring compliance with global regulatory requirements and driving program success

Key Responsibilities:

  • Lead stability programs and act as Stability Product Lead for assigned brand(s)
  • Review registrational stability studies and conduct gap analysis against Global Manufacturing & Supply requirements
  • Develop stability data where gaps exist and maintain expertise on the overall stability performance of products
  • Author stability sections of regulatory filings and respond to health authority inquiries
  • Lead investigations related to potential quality issues and deviations from standards
  • Represent the department in cross-functional projects and support health authority inspections

Top Technical Skills:

  • Expert knowledge of stability ICH Guidelines and cGMP regulations
  • Familiarity with US/EU/ROW requirements and industry best practices
  • Understanding of Drug Substance and Drug Product manufacturing processes
  • Proficiency in statistical analysis software for evaluation and interpretation of stability data
  • Experience with LIMS, Quality Management systems, and Microsoft Office applications

Experience and Education:

  • Bachelor’s degree in Chemistry, Biology, Microbiology, or relevant discipline required
  • Minimum 8 years of relevant work experience in the pharmaceutical industry

If you’re a dynamic and experienced Stability Scientist seeking a challenging role in pharmaceutical stability and regulatory affairs, we encourage you to apply now and become part of our team!

About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
 

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