Laboratory technician for sterile liquids and semi-solids Clinical Manufacturing Unit.
You will be part of a project to start a new clinical manufacturing unit to support in-house development and manufacturing of sterile liquids and semi-solids dosage forms. You will integrate a team and participate in activities supporting the Clinical Manufacturing unit readiness (e.g. validation's activity including room qualification, equipment IQ/OQ/PQ, media simulation, etc.).
- Draft SOP and review of relevant documentation link to the new facility
- Formulation and manufacturing process development of liquid forms under aseptic conditions/
Planning and execution of experiments and IPC tests
- Manufacture of batches and documentation of the manufacturing process according to cGMP for clinical trials and beginning of commercial
- Technical development documentation, incl. the first assessment of the results; support drafting of master batch records, archiving
- Operation / cleaning of rooms and equipment according to SOPs
- Contributing to manufacturing and cleaning procedures, reports and instructions and / or SOP's and to the evaluation of new manufacturing or lab equipment
- Support of inspections by internal or external authorities
- Bachelor's degree in pharmacy / chemistry with minimum 3 years of industrial experience or Education as a laboratory technician, with more than 5 years of experience in pharmaceutical formulation development combined with cGMP manufacture. Knowledge in microbiology is an advantage.
- Profound technical knowledge in liquid filling (syringes and vials) and aseptic practices as well as basic knowledge in visual inspection
- Solid experience in optimizing existing processes and contributing to new process development
- Good know-how of technical tools along with sufficient knowledge of software and computer tools
- Languages: fluent English both written and spoken
- Team spirit, good communication skills and ability to work with multi-disciplinary team including external suppliers and scientists
- Sense of responsibility, accuracy and ability to perform various task with little guidance
- Readiness to work in cGMP environment (with respective clothing, hygiene and behaviour requirements) and to work in personal protection equipment in a highly challenging environment for extended time (e.g. full-face masks, gloves etc. in grade A and B)