Scientist Drug Product Laboratory (m/f/d)


  • Degree (bachelor, master, diploma) in Life Science, Pharmaceutical Sciences or a comparable field
  • Relevant work experience in the pharmaceutical industry with experience in a GMP environment
  • At least, intermediate knowledge in protein chemistry and drug product specific analytics particularly in the field of subvisible particulate analysis (light obscuration, membrane microscopy, flow imaging microscopy)
  • Plan and execute routine measurements according to USP <789> for ophthalmic drug products
  • Plan and perform the qualification/verification of the methods related to USP <789> in house and be author of related documentation, as needed
  • GMP analysis according to German Medicinal Law (AMG): Performance and documentation of tasks according to GMP requirements
  • Supervise external testing labs for above mentioned methods and be author of related documentation, as needed
  • Take over responsibility for one or more analytical testing equipment, including qualification and maintenance according to GMP requirements
  • Design and perform lab experiments, ensure appropriate documentation (preparation of plans, protocols, reports) for drug product formulation, process development as well as process characterization, in collaboration with the Formulation and Process Development colleagues and in agreement with current Quality by Design principles
  • Produce high quality documentation and presentations of performed studies and present them to internal and external partners


» Job description


Employer:
Formycon AG
Location:
82152 Planegg-Martinsried