AbbVie Senior Scientist Analytical Development in Ludwigshafen, Germany
Senior Scientist Analytical Development
Germany, Rhinland-Palatinate, Ludwigshafen
Research & 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.