Senior Stability Scientist

2 weeks ago


New Brunswick, New Jersey, United States LanceSoft, Inc. Full time

Position Title: Senior Stability Scientist

Company: LanceSoft, Inc.

Job Overview:

The Senior Stability Scientist plays a crucial role in formulating and overseeing the stability strategies for pharmaceutical products, specifically focusing on small molecules in both oral and sterile forms.

Key Responsibilities:

  • Develop and manage comprehensive stability product strategies and programs.
  • Author and approve stability protocols, ensuring compliance with industry standards.
  • Prepare, review, and validate stability reports and regulatory submissions.

Essential Qualifications:

  • A minimum of 8 years of expertise in managing stability programs for small molecule products.
  • In-depth knowledge of ICH stability guidelines and cGMP regulations.
  • Proven experience in New Product Introduction processes.
  • Strong understanding of Regulatory CMC requirements for stability in US, EU, and ROW markets.
  • Hands-on experience in addressing QC deviations and interpreting results.

Required Skills and Competencies:

  • Expertise in ICH Guidelines (Q1A, Q5C) and relevant policies.
  • Thorough understanding of cGMP regulations as outlined in The Code of Federal Regulations (21CFR).
  • Extensive knowledge of US/EU/ROW regulatory requirements and industry best practices.
  • Familiarity with Drug Substance and Drug Product manufacturing processes and analytical methods.
  • Strong analytical skills to drive scientific initiatives and resolve complex issues.
  • Experience in drafting and critically reviewing investigations and technical conclusions.
  • Proficient in evaluating stability data using statistical software and identifying trends.
  • Experience overseeing external partners involved in stability studies.
  • Significant experience with health authority inspections related to stability programs.


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