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
Don't forget to mention EuroPharmaJobs when applying.