We are looking for a Pharmaceutical Development Scientist / Technical Writer. Your responsibility will be to optimize and validate manufacturing processes for pharmaceutical compounds intended for clinical trials. This position involves both hands-on pharmaceutical experiments, development, and validation tasks, as well as drafting scientific documentation.
you will conduct lab experiments in collaboration with experienced production technicians, focusing on method setup and/or optimization during the development phase. You will also contribute to process validation experiments alongside the production and QC teams. Once validation is complete, you will play a key role in training new technicians and resolving process-related issues.
In addition to the above responsibilities, you are primarily responsibility will be to optimize and validate automated manufacturing processes for pharmaceutical compounds intended for clinical trials. A significant aspect of your work will involve contributing to the establishment of a validation strategy and drafting scientific documentation required for clinical manufacturing in compliance with GMP and ICH guidelines. This includes preparing procedures, validation plans, scientific reports, and chemical and pharmaceutical data for the Investigational Medicinal Product Dossier (IMPD).
Key Tasks and Responsibilities:
- Assist in establishing clinical production processes for pharmaceutical investigational medicinal products (IMPs), progressing from test synthesis to a validated GMP-compliant manufacturing process.
- Contribute to the development of a validation strategy in alignment with ICH standards.
- Prepare and review documentation, including feasibility study reports, procedures, validation plans, and validation reports.
- Support the Head of Development in managing project documentation and timelines.
- Perform pharmaceutical syntheses activities using automated synthesis modules in a cleanroom environment during the development phase.
- Present results in a structured and professional manner, both verbally and in writing.
- Ensure compliance with all applicable regulations regarding radiation safety and Good Manufacturing Practices (GMP).
Requirements:
- A completed BSc or MSc degree in a relevant field (e.g., organic or analytical chemistry, chemistry, or biochemistry).
- Very strong English communication skills and a proven ability to draft scientific and technical documentation.
- Demonstrated experience in drafting scientific and technical documentation.
- You excel at summarizing scientific content and validation strategies.
- You can easily translate laboratory procedures into precise and structured documentation.
- You possess excellent organizational skills
- Are able work with individuals from diverse backgrounds, including internal team members and international external partners.
- You are able to manage multiple projects simultaneously and keep track of deliverables and timelines.
- Familiarity with working in a GMP-compliant environment and cleanrooms
- At least two years of relevant laboratory experience in industry or academia, preferably in the pharmaceutical field
Benefits:
- Contract: start via Oxford Global Resources - Prospect of a permanent contract
- Salary: €3300 to €4400 per month
- Hours: 36 hours per week.
- Location: Nijmegen.
- Vacaturenummer: 25236
