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Research and Development Chemist

2 months ago


South Bend, Indiana, United States Tri Pac, Inc. Full time
Job Description:

This is a new position that will play a critical role in our site stability program, formulation, and stability sampling activities. The R&D Chemist-Stability Coordinator will be responsible for coordinating and supporting the site stability program, formulation, and stability sampling activities in compliance with the FDA ICH guidelines, company quality guidelines, SOP's and other regulatory requirements.

Key Responsibilities:
  • Report to the R&D Manager and work onsite at our facility
  • Initiate stability studies, coordinate stability pulls, and ensure testing schedules are met
  • Analyze stability data, evaluate trends, and write stability reports
  • Author stability protocols, interim reports, and reports for stability studies
  • Manage stability studies following internal procedures and ensure studies are set up per the protocol
  • Interact with other groups in R&D and other departments as required
  • Collaborate with relevant QC laboratories to ensure stability samples are tested within their specified time frame
  • Coordinate the shipment of stability samples to outside labs when required
  • Maintain stability trackers for routine annual stability and lab stabilities
Requirements:
  • Associate or bachelor's degree in a scientific discipline
  • 2 or more years of related experience and/or training
  • Must demonstrate knowledge of common analytical tools and techniques
  • Must have previous experience with conducting stability studies and knowledge of statistics
  • Must have previous experience in a GMP environment
Benefits:
  • Competitive salary and benefits package
  • Vacations and insurance
  • 401K and life insurance
  • Disability (long-term/short-term) and continuous training
  • Education assistance to encourage continued personal development and growth