Principal Stability Scientist

New Brunswick, New Jersey

Employer: Piper Companies
Industry: 
Salary: $65 - $68 per hour
Job type: Full-Time
Piper Companies is looking for a Principal Stability Scientist to be responsible for stability product strategy and oversight of product stability programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile working for a Biotechnology company in New Brunswick, NJ .

Responsibilities for the Principal Stability Scientist include:
  • Participates on transfer team for new products to internal and external sites
  • Develops and maintains expertise on the overall stability performance of products manufactured in the globa l supply chain
  • Serves as stability representative on project teams covering post-approval changes
  • Provide the technical requirements in a Master Stability Protocol
  • Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries.
  • Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards.


Qualifications for the Principal Stability Scientist include:
  • B.S. Chemistry, Biology, Microbiology or relevant discipline
  • 8+ years of experience in Stability Program Management for small molecules (oral and sterile product)
  • Strong understanding of stability ICH guidelines and cGMP regulation
  • Experience with New Product Introduction
  • Very good understanding on Regulatory CMC , US/EU/ROW submission requirement for stability
  • Hand on experience on handling QC Deviation OOS / OOT, authorship, interpret results


Compensation for the Principal Stability Scientist include:
  • 12- month consulting assignment, opportunity to extend/convert thereafter
  • Hourly Rate: $65-$68/hour
  • Full Cigna Benefits
  • 2 weeks PTO, 6 Paid Holidays, 401k
Created: 2024-05-08
Reference: 120246
Country: United States
State: New Jersey
City: New Brunswick

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