Head of Laboratory Analytical Development (m/f/d)
- In your new role as Head of Laboratory Analytical Development you will be responsible for the technical and managerial leadership of a laboratory with focus on ELISA, Biacore and/or HPLC, CE based methods within the group Analytical Development.
- You will assure state-of-the-art method development, perform pre-validation for DS and DP for toxicological supplies and transfer to Quality Control departments - as well as providing characterization data and performing comparability assessments for biopharmaceutical products throughout the whole project life-cycle.
- The provision of high quality submission documents for CTAAs and MAAs - Analytical Team Member in Biopharma projects will be one of your key tasks.
- You will ensure timely release of biopharmaceutical DS & DP for development and toxicological studies and develop concepts for analytical characterization and comparability studies in the function of "Analytical Team Member".
- In addition, you will support provision of high quality analytical submission documentation for CTAAs, MAAs and post-approval regulatory changes.
- Furthermore, you will provide leadership and ensure an inspiring, creative, innovative, trust worth, continuous learning, and proactive culture.
- PhD in Biosciences with strong focus on analytical technologies in the pharmaceutical industry or Master's degree in Biosciences and several years' relevant experience
- Strong scientific expertise in analytical and protein chemistry
- Leadership and working experience in an international environment is a plus
- Very good communication, negotiation and presentation skills in English and German (fluent)
Boehringer Ingelheim GmbH