Reporting to the Head of R&D you will conduct activity of experimental work in the area of R&D with a focus on API process development (Scale-up) of pharmaceutical and chemical products. Support in organizational as well as safety-related tasks.
KEY RESPONSIBILITIES:
- Carrying out all activities in small molecule API/chemical research and development in accordance with ISO and cGMP standards.
- Take a leading technical duty of projects as assigned by the management.
- Carrying out chemical processes including synthetic chemistry.
- Carrying out analytical measurements, such as HPLC, GC-MS, GC, LC-MS
- Organization of lab work including waste disposal management
- Collaboration in the supervision of trainees
- Support in the preparation and follow-up of internal and external audits
- Assisting in the development of optimized production processes in compliance with the necessary regulations
- Assistance in the implementation of production processes and sample production
- Collaboration in the creation and introduction of development reports / batch records, standard operating procedures (SOPs),
- Collaboration in the implementation of qualifications and validations in production and quality control
- Carrying out all activities in compliance with the HACCP concept and in compliance with all relevant specifications
- Technical support as well as carrying out regular maintenance/calibration work on laboratory and pilot equipment
QUALIFICATIONS & EXPERIENCE:
- BSc or similar qualification in chemistry.
- Completed training as a chemical laboratory assistant, pharmaceutical technical assistant, chemical technical assistant, or similar.
- Laboratory experience in synthetic chemistry
- Work experience in the pharmaceutical or chemical industry
- Advanced chemical knowledge and analytical skills
- Experience in a pharmaceutical industry environment with understanding of cGMP regulations desired
- flexibility to be able to work on extended working hours when needed
- Hands-on experience with laboratory analytical equipment such as NMR, GC, HPLC, UV-Vis, titrations, etc.
- Advanced knowledge of process development and separation technologies (e.g., distillation and chromatography)
OTHER:
- Working in line with current company cGMP procedures including all relevant SOP's and guidelines.
- Ensuring that work is carried out in accordance with appropriate EHS Procedures.