Associate Principal Scientist Process Development Drug Product

Associate Principal Scientist Process Development Drug Product

Lonza

Basel, Switzerland

What you will 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) and small molecules
• Document data following applicable lab procedures and current documentation practices
• Act as project lead for assigned projects, being the customer’s SPOC for DPS activities
• Enable innovation and technical strategy projects, generate IP and contribute to scientific publications
• Execute analytical tests to support formulation and process development (e.g. HPLC and CE purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, visible particles, subvisible particles)
• Manufacture non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques
• Support manufacture of clinical drug supplies at GMP sites

What we are looking for:

• Science or engineering degree (PhD, MSc) in a relevant discipline, e.g. Pharmaceutical Sciences, Chemical or Biochemical Engineering, or a training on the job as lab technician, or equivalent
• Work experience as a research/technical assistant in the pharmaceutical or chemical industry, preferably in process development
• Understanding of Drug Product process development, and technical knowledge of handling basic analytical equipment e.g. UV-VIS, pH, osmolality
• 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
• Strong communication skills and ability to work independently within a team
• Excellent knowledge of written and spoken English