Stability Scientist

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.