Senior Scientist Process Development Drug Product

Senior Scientist Process Development Drug Product

Lonza

Basel, Switzerland

What you’ll do:

• Assist establishment of Drug Product process development infrastructure and services for parenteral drug products for clinical and commercial use;
• Install, qualify, and maintain equipment for process development, non-GMP manufacturing and related analytics in close alignment with current best practices and regulations;
• Plan and perform process development and characterization studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides), peptides and small molecules;
• Supervision of the junior scientists or interns when required;
• Document data following applicable lab procedures and current documentation practices;
• Good understanding on Annex1 and the implication on GMP Drug product manufacturing process (e.g. Filtration, Mixing and Compounding, Hold-time, Ambient light, VHP uptake);
• Support manufacture of non-clinical and clinical drug supplies at GMP sites.

What we’re looking for:

• Science or engineering degree (BSC or MSc) in a relevant discipline, e.g. Pharmaceutical Sciences, Chemical or Biochemical Engineering;
• Minimum 3 years of experience in pharmaceutical or chemical industry, preferably in process development;
• Working experience in relevant pharmaceutical development and manufacturing technologies. Experience with parenteral dosage forms, protein formulation and analytics and aseptic working techniques is a plus;
• Very good knowledge of reporting, interpretation and documentation of scientific results;
• Experience with parenteral dosage forms and/or lyophilization techniques is a plus;
• Ability to work independently in a team environment, with attention to detail and proactive attitude. Good knowledge of written and spoken English. Any other languages are a plus.