Associate Scientist – Stability Programs

New Brunswick, New Jersey

Job Title: Associate Scientist – Stability Programs

Location: 100% onsite at New Brunswick, NJ

Join our dynamic team as an Associate Scientist, specializing in Stability Programs. You’ll be part of a team that manages stability programs for our client’s commercial biologics Drug Substances and Drug Products, supporting both internal and external manufacturing sites.

Key Responsibilities:

  • Oversee end-to-end management of biologics marketed product stability programs.
  • Determine and communicate stability requirements, assisting with identifying production batches for inclusion in the stability program.
  • Perform change control impact assessments and author change controls for changes to stability program/operations.
  • Review and approve modifications to Master Stability Protocols and LIMS stability studies.
  • Perform stability data analysis/trending in support of regulatory submissions, Annual Product Quality Reviews, and internal reports.
  • Serve as a stability subject-matter expert on project teams related to pre-market and post-approval changes.

Skills Required:

  • Bachelor’s degree in a relevant field.
  • Strong knowledge of stability ICH Guidelines (Q1A, Q5C) and cGMP regulations.
  • Excellent written and verbal communication skills.
  • Ability to work collaboratively in a team matrix environment.
  • Experience with evaluating and interpreting stability data using statistical software.
  • Working knowledge of biologics drug substance manufacturing and drug product filling operations.

Join us and contribute to our mission of delivering high-quality biologic products. We look forward to welcoming you to our team!

About SSi People: 
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

 

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