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Eurofins Scientific
4d ago

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

Sankt Gallen
Full-timeOn-siteSenior

Description

You will drive the transition from development to GMP manufacturing by managing CDMO partnerships and ensuring process robustness through rigorous Quality by Design and data analysis.

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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

Education

Master's degree
OR
Doctoral / PhD
OR
Bachelor's degree
OR
Vocational certification

Work Experience

5 - 8 years

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

Tools & Technologies

GMPQbDICH Q8–Q11 guidelinesSOPs

Languages

English – Business Fluent

German – Basic

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