Principal Scientist Stability

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  • Date de publication :

    26 mars 2024
  • Taux d'activité :

    100%
  • Type de contrat :

    Durée indéterminée
  • Langue :

    français (Intermédiaire), anglais (Intermédiaire)
  • Lieu de travail :

    2000 Neuchâtel

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

rue du Rhône 114 1204 Geneve

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