Principal Scientist Stability
Principal Scientist Stability
For our client in biopharmaceutical industry, Kelly Life Science is looking for a:
Principal Scientist Stability
(Temporary position)
Your mission:
- responsible for stability product strategy and oversight of product stability programs
Your responsibilities:
- 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
Your profile:
- 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
Your contact at Kelly:
Manon Tenaud 022 737 12 07