Stability Scientist

4 weeks ago

New Brunswick, United States Sunrise System Inc Full time

100% onsite

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.



Required Knowledge/Skills/Qualifications:

  • Education: Required B.S. Chemistry, Biology, Microbiology or relevant discipline
  • Experience/Knowledge: 8 years of relevant work experience required, preferable in a Pharmaceutical
  • environment.



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.
  • Excellent written and verbal communication skills
  • Exhibit strong leadership and decision making skills.
  • Advanced ability to work independently and collaboratively in a team matrix environment, contribute to a team based environment, promoting a high commitment to business goals and objectives.
  • Advanced ability to prioritize objectives from multiple projects and ability to adapt to quick changes in schedules in order to accommodate priority requests.
  • Advanced knowledge of Microsoft office applications , LIMS, Quality Management system (e.g. TrackWise or Veeva), Statistics software (e.g. SlimSTAT, JMP).

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