Research Associate E&L (mfd)

What youll be doing

• Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support extractables & leachables projects and change control activities

• Collaborate with a multidisciplinary team of subject matter experts (e.g. Materials Biocompatibility and Toxicology) to develop E&L strategies that align to regulatory requirements for medical devices and drug products

• Plan laboratory work in mass spectroscopy and E&L including independent execution of laboratory studies at in-house or external labs

• act as study director for multiple studies at any given time and is expected to be able to do wet chemistry and mass spectroscopy (GC LC and other appropriate methods)

• Perform E&L change control impact assessments and work with cross functional team members (design owners materials preclinical etc.) to determine a comprehensive testing strategy through writing impact assessments gap assessments technical rationales and documents related to E&L

• Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development design and safety

• Interact across functions (Design Owning Organization Project Management Organization Regulatory Affairs Preclinical etc.) to understand products and therapiesas well as business technical and regulatory requirements to meet project needs

What youll bring

• Bachelors degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum of 7 years of relevant experience or MS with a minimum of 5 years of relevant experience or PhD with a minimum of 3 years of relevant experience

• Hands-on Experience and demonstrated knowledge in E&L testing (from wet chemistry sample preparation to Mass spectroscopy using GC and LC methods)

• Study director experience in leading scientific studies working in cross-functional teams and on-time on-budget-project execution

• understanding regulatory expectations and writing cohesive and concise E&L reports for submission to the health authorities

• understanding of polymer chemistry

• performing change control in a GMP environment

• being an independent problem solver who can use a methodical approach to develop solutions perform root cause analysis make and implement recommendations.

• Fluent in English and good understanding in German

Have we sparked your interest

If you like the sound of the above role can thrive in a fast-paced working environment and are excited about working in a learning and growth culture then wed love to talk to you. Apply direct on our Online System.

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