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gloor&lang AG
Scientist Stability (mfd) – Hybrid Rolegloor&lang AG • Neuchâtel, Neuchâtel, Switzerland
Scientist Stability (mfd) – Hybrid Role

Scientist Stability (mfd) – Hybrid Role

gloor&lang AG • Neuchâtel, Neuchâtel, Switzerland
Vor 30+ Tagen
Stellenbeschreibung

Stability testing Drug Substance/Product 7-Months contract

Exciting Opportunity in a Global Pharmaceutical Environment
For our client a leading international biopharmaceutical company we are currently looking for a motivated and experienced Scientist Stability to join the Global Biopharmaceutical Stability team.

In this role you will be responsible for stability strategies and oversight of commercial Drug Substance and Drug Product stability programs within a highly collaborative global environment.

Your Responsibilities

  • Act as Stability Product Lead for assigned commercial products
  • Develop and oversee stability strategies and stability programs
  • Author review and approve stability protocols and reports
  • Support regulatory submissions including CTD dossiers annual reports and product renewals
  • Participate in product transfers and perform gap assessments against global requirements
  • Support Change Controls CAPAs OOT/OOS investigations and quality-related activities
  • Coordinate annual commercial stability programs with sample management teams
  • Collaborate with cross-functional international teams and external partners
  • Support health authority inspections and audits
  • Contribute to Operational Excellence initiatives to improve and standardize stability processes

Your Profile

  • Bachelors degree in Chemistry Biology Microbiology or a related scientific discipline
  • Minimum 35 years of experience in the pharmaceutical industry
  • Strong knowledge of ICH Stability Guidelines (Q1A Q5C) and cGMP requirements
  • Experience with stability studies quality systems and regulatory documentation
  • Familiarity with statistical software such as JMP or SlimSTAT is an advantage
  • Experience with LIMS and Quality Management Systems (e.g. TrackWise or Veeva)
  • Strong analytical organizational and problem-solving skills
  • Ability to work independently in a matrix organization
  • Excellent communication skills in French and English

Employment Type : Employee
Experience: years
Vacancy: 1
Jobalert für diese Suche erstellen

Scientist Stability (mfd) – Hybrid Role • Neuchâtel, Neuchâtel, Switzerland

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