Senior Scientist Analytical Development
Act as subject matter expert for analytical method development/analytical control strategy within NBE Analytical R&D LU. Responsible for analytical method development and qualification, associated transfer activities into quality control areas, as well as support of QC related activities like clinical trial supply releases or stability programs to successfully drive pipeline and life cycle management of NBE projects.
- Responsible for the evaluation, optimization and establishment of innovative analytical methods to characterize and control active pharmaceutical ingredients, stabilizers and excipients in drug substances and drug products as well as related impurities during pharmaceutical development of biological products.
- Establish and continuously improve approaches related to NBE analytical development concepts across project portfolio
- Assess analytical test methods for quality control and characterization purposes
- Create source documents for agency applications and publications
- Interpret analytical data and conclude quality relevant parameters
- Ensure GMP compliant documentation
- Build strong cross-functional networks in a local and global environment
- Responsible for subject matter expert topics and representation in local and global teams.
- PhD degree in chemistry, (structural) biology, pharmacology, food chemistry, analytical chemistry or related field
- At least 3 years of relevant industry experience in the area of pharmaceutical development of biologics
- Demonstrated expert knowledge and experience in analytical development for new biological entities (NBE), especially development of new innovative and established analytical methods for protein characterization. Candidate’s portfolio should consist of chromatographic separation techniques like HPLC/UPLC coupled to various detection systems, capillary gel electrophoresis, as well as quantification and characterization of stabilizers in formulations (e.g. polysorbate) or other excipients in antibody formulations.
- Experience in Quality by Design (QbD) and Design of Experiment (DoE) are beneficial
- Experience in other NBE related areas like formulation, process development, manufacturing or quality control are beneficial
- Strong analytical and problem-solving capabilities and skills
- Excellent understanding of both scientific and regulatory requirements in the area of pharmaceutical development
- Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills
- Experience in a cross-functional, global environment, used to work with teams in a matrix
- Excellent team player with the ability to build strong networks with Peers
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.