Analytical Expert (m/f)

With 30,000 employees in 70 countries, Takeda is one of the most innovative pharmaceutical companies in the world. We develop active pharmaceutical ingredients and integrated therapy approaches against diseases for which there is no cure for yet. Every day, our employees take on responsibility for more health. From prevention to treatment to care. In doing so, we pursue one objective: to improve people’s lives. In Germany, about 2,000 people at four locations support us on this mission. Become a part of Takeda and help us create tomorrow’s health solutions.
We are looking for

a candidate

for the position Analytical Expert (m/f) within the department

Quality Services & Improvement

. The position is based in

Singen

, Germany.
Your Responsibilities

 

 

  • QC expert for aseptic and sterile products, e.g. for container closure integrity test, extractables and leachables studies
  • Compilation of risk assessments
  • Development and validation of analytical methods for characterization of active pharmaceutical ingredients (SMOLS and Biopharmaceuticals) and their drug products
  • Supporting root cause problem solving
  • Statistical evaluation and interpretation of results
  • Compilation of method development and validation reports, analytical procedures and SOPs in German and English
  • Transfer of analytical methods to quality control labs

 

 

 

 

 

 

Your Profile

 

 

  • Preferably Degree in Natural Sciences, chemistry, biology or pharmacy (B.Sc./M.Sc.)
  • 5-7 years of GMP experience in Pharmaceutical/ Biotechnological Industry in areas of Analytical Development or Quality Control
  • High knowledge and experience in analytical and physical chemistry with focus on chromatography (HPLC/UHPLC, LC-MS), spectroscopy (UV-Vis, IR, NIR), titration, particle analysis
  • Knowledge of GMP/Quality Management Systems
  • Fluent in German and English
  • Experience in Method Development
  • Experience with aseptic and sterile products desirable
  • High knowledge in Microsoft Office
  • Well-organized, well-structured and team orientated
  • Good analytical and social skills