Senior Scientist (m/f/d)

Your Profile:

• Degree in Life Sciences, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
  
• Extensive experience within a GMP or GLP-regulated laboratory environment, with significant expertise in Gas Chromatography.
  
• Strong knowledge of chromatographic method development, validation, transfer, verification, and troubleshooting.
  
• Experience working with pharmacopoeial methods and requirements (USP, EP, BP, JP or equivalent).
  
• Excellent understanding of GMP, data integrity, and regulatory compliance requirements.
  
• Strong leadership, communication, problem-solving, and report-writing skills.
  
• Ability to build effective client relationships and provide technical guidance, mentoring, and training.

Your Tasks:

• Act as the technical lead and subject matter expert for Gas Chromatography across the Chemistry department.
  
• Perform and oversee complex analytical testing to support biopharmaceutical products and projects within a GMP-regulated laboratory environment.
  
• Lead and support method development, validation, verification, transfer, and optimisation activities.
  
• Provide technical guidance, troubleshooting expertise, and scientific support for chromatographic methods and instrumentation.
  
• Conduct technical reviews, data reviews, and batch audits to ensure compliance with GMP, data integrity, and regulatory requirements.
  
• Lead root cause investigations, quality risk assessments, CAPAs, change controls, and other quality-related activities.
  
• Develop, review, and approve analytical procedures, protocols, reports, and controlled GMP documentation.
  
• Build and maintain strong client relationships through technical discussions, project support, audit participation, and inter-company collaboration.
  
• Support regulatory inspections, client audits, self-inspections, continuous improvement initiatives, and the delivery of technical training across the department.

» Job description