Die Stelle
04What 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.
01Execute 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.
02Support install, qualify, and maintain equipment and lab for pharmaceutical development and associated analytics in close alignment with current best practices and regulations.
03Support plan and perform pharmaceutical development studies for liquid and lyophilized parenteral drug products of biologics (e.g. monoclonal antibodies, novel formats, ADCs, peptides).
04Document data following applicable lab procedures, current documentation practices and complying with data integrity standards.
05Evaluate results and summarize in short reports.
06Support 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).
07Support manufacturing non-GMP drug product samples for supportive stability studies and preclinical use (e.g. GLP tox studies) applying aseptic working techniques.
08Ensures basic GMP qualification and performs documentation, material handling and use of equipment according to applicable quality standards.
09Ensure compliance to health and safety standards.
