Specialist Stability

Posted 24 November 2021
SalaryNegotiable
LocationNeuchâtel
Job type Limited
DisciplineScience
ReferenceBBBH496720_1637766095

Job description

For our client, a pharmaceutical company based in Canton of Neuchatel, Kelly Life Sciences is looking for a:

Stability Specialist

(Temporary position)

Your Missions

  • The Specialist Stability is responsible for handling the stability program for all commercial products internally and externally.
  • Performing tracking and trending stability data results.
  • Key Subject Matter Expert in commercial drug product and drug substances stability.

Your Duties

Commercial Stability program:

  • Responsible for the handling of commercial stability program for Celgene products: scheduling, batch selection, setup, sampling, coordination, etc.….
  • Responsible for the creation of stability protocol as well as Master Data management and the creation of stability study (e.g.LIMS system)
  • Track and trend stability data for commercial products internally and externally
  • Participate in external and internal audits
  • Responsible for the global stability SOP / WP

Reporting:

  • Responsible for the annual stability report
  • Manages the master data for stability samples
  • Support the management of global reference standards and control products

Support Commercial drug substances and drug product:

  • Collaborates with QA on deviations
  • Leads work activities involving Change Controls and CAPA's
  • Represents department in cross functional projects

Your Profile

  • S. Chemistry, Biology, Microbiology or relevant discipline
  • 5 years of relevant work experience required, preferable in a pharmaceutical environment
  • Advanced understanding of pharmaceutical regulatory requirements and their impact to commercial laboratory operations
  • Advanced knowledge in stability protocol definition
  • An equivalent combination of education and experience may substitute
  • Advanced knowledge in English and French

Your Application

Please apply online, Aymeric Shimamungu will be pleased to talk with you.