Principal Scientist Stability

• responsible for stability product strategy and oversight of product stability programs

• Participates on transfer team for new products to internal and external sites
• Conducts gap analysis and develops stability data where gaps exist.
• Develops and maintains expertise on the overall stability performance of products manufactured
• Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change
• Perform change control impact assessments and document the stability assessment in change controls.
• Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms
• 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
• Leads work activities involving Change Controls and CAPA’s
• Participate and/or lead OpEx initiatives to streamline and standardize management of stability programs
• Ensure training requirements are met
• Acts as an advisor and mentor to stability staff

• BSc Chemistry, Biology, Microbiology or similar
• Minimum 8 years’s experience in Pharmaceutical environment
• Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C)
• Knowledge of cGMP
• Knowledge of Drug Substance and Drug Product manufacturing and good understanding of analytical and/or Microbiology methods
• Experience with authorship and able to critically review investigations, interpret results, and generate technical conclusions
• Advanced knowledge of Microsoft office, LIMS, QMS, Statistics software (e.g. SlimSTAT, JMP).
• French and English

Kelly Services