Scientist Process Development

Scientist Process Development

Lonza

Basel, Switzerland

What you will do:

• Execute in the laboratory and report small scale pharmaceutical process development studies for parenteral (mixing hold time, VHP stress, filtration, filling behaviour and lyophilization) studies under the supervision of a senior scientist;
• Support install, qualify, and maintain equipment and lab for pharmaceutical development and associated analytics in close alignment with current best practices and regulations;
• Support plan and perform pharmaceutical development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides);
• Document data following applicable lab procedures, current documentation practices and complying with data integrity standards. Evaluate results and summarize in short reports;
• Support implementation and execution of analytical tests for pharmaceutical development (e.g. HPLC and CE purity methods, content by UV, identity, color, clarity and opalescence, pH, osmolality, visible particles, subvisible particles);
• Support manufacturing non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques;
• Ensures basic GMP qualification and performs documentation, material handling and use of equipment according to applicable quality standards. Ensure compliance to health and safety standards.

What we are looking for:

• Science or engineering degree (MSc) in a relevant discipline, e.g. Pharmaceutical Sciences, Chemical or Biochemical Engineering, or a training on the job as lab technician, or equivalent;
• Knowledge in the process steps of fill and finish for parenteral pharmaceutical products. Ideally experience in a process development lab for pharmaceuticals;
• Very good knowledge of reporting, interpretation and documentation of scientific results;
• Good communication skills;
• Excellent communication skills with excellent command of English, written and spoken.