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EUEurofins Scientific

Drug Substance Scientist / Manager (CMC – API)(m/w/x)

Sankt Gallen
Full-timeOn-siteSenior

Evaluating CDMO development proposals and manufacturing data for active ingredients. 5-8+ years small-molecule active ingredient manufacturing experience required. International project exposure.

Requirements

  • MSc, PhD in Chemistry or related
  • Bachelor, FH degree in Chemistry or related
  • Laborant EFZ Chemie with industry experience
  • Industrial exposure and non-academic background
  • 5–8+ years small-molecule API industry experience
  • Hands-on experience working with CDMOs
  • Familiarity with GMP and batch documentation
  • Knowledge of QbD and ICH guidelines
  • Ability to interpret process data
  • Excellent technical writing skills
  • Clear and structured communication
  • Detail-oriented and compliant work style
  • Proficiency in English and beneficial German

Tasks

  • Contribute to Quality by Design activities
  • Perform CQA and comparability assessments
  • Conduct process FMEA and parameter criticality
  • Evaluate CDMO development proposals and manufacturing data
  • Analyze deviations and campaign performance
  • Support GMP-compliant API production
  • Review batch records and investigations
  • Manage change controls and CDMO interactions
  • Define and track technical and operational KPIs
  • Prepare reports and presentations for internal teams
  • Support the setting of API specifications
  • Update SOPs for QbD and process development
  • Identify and implement CMC digitalization needs
  • Develop internal training for QbD concepts

Work Experience

  • 5 - 8 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent
  • GermanBasic

Tools & Technologies

  • GMP
  • QbD
  • ICH Q8–Q11 guidelines
  • SOPs
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