Stability Scientist

2 weeks ago

New Brunswick, United States LanceSoft, Inc. Full time

Title: Stability Scientist

Location: New Brunswick, NJ 08903

Duration: 12 Months


Job Description:

Principle Objective of Position:

  • The Principal Scientist Stability is responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile.
  • Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings.


Must Haves:

  • 8+ years of experience in Stability Program Management for small molecules (oral and sterile product)
  • Strong understanding of stability ICH guidelines and cGMP regulation
  • Very good experience on New Product Introduction
  • Very good understanding on Regulatory CMC, US/EU/ROW submission requirements for stability
  • Hand on experience on handling QC Deviation OOS / OOT, authorship, interpret results


Skills/Competencies:

  • Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C) and associated policies, directives and guidance documents.
  • A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to stability programs in a pharmaceutical manufacturing facility.
  • Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and industry best practices.
  • Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods.
  • Very good skills to drive development of technical or scientific initiatives for solving complex problems/issues; recommending and drive science-based decisions/ implementation of solutions.
  • Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality management principles
  • Good Knowledge of evaluation and interpretation of stability data using statistics software. Review data and demonstrated ability to recognize anomalous trends or results
  • Experience to oversee external service providers involved in stability studies.
  • Significant experience on health authorities inspections on stability programs.

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