Scientist (f/m/d) - GMP Services

Purpose of your Job

Our GMP team is looking for a Scientist to support laboratory operations in a GMP-regulated environment.
In this role, you will be responsible for executing analytical tests and experiments with precision, ensuring compliance with GMP guidelines. You will contribute to the implementation and qualification of new analytical equipment, support validation and qualification activities, and oversee laboratory equipment maintenance. Additionally, you will be involved in method transfers, SOP development, and quality assurance processes such as deviations, CAPA, and change control.

Your Responsibility

• Act as a Project Leader or team member in customer projects.
• Ensure the accurate and timely execution of tests and experiments, strictly following relevant testing procedures or experiment plans agreed upon with the project manager within a GMP-regulated environment.
• Support the implementation and qualification of new analytical equipment and techniques in compliance with GMP regulations.
• Serve as System Owner for laboratory equipment, overseeing maintenance and qualification.
• Participate in validation and qualification projects, contributing to the development and execution of plans, protocols, and reports.
• Prepare and review Standard Operating Procedures (SOPs) and testing procedures.
• Execute Coriolis QA processes, including deviation management, CAPA, change control, and OOS investigations.
• Ensure general laboratory cleanliness and compliance with GMP standards.
• Contribute to the development and compilation of work plans, testing procedures, and reports for customer projects.
• Perform method transfers in accordance with GMP regulations.

What you need to succeed

• Higher university degree in pharmacy, (bio)chemistry, biotechnology, biophysics, or a related field (PhD preferred).
• Documented training in GMP regulations and Quality Management Systems.
• Hands-on experience in general laboratory work and analytical techniques.
• Strong analytical background with expertise in relevant methodologies.
• Basic understanding of GMP regulations and quality management principles.
• Solid knowledge of qualification processes.
• Strong expertise in analytical method development and validation.
• Proficiency in English, both written and verbal.
• Excellent teamwork skills with a collaborative and solution-oriented mindset.
• Effective communication skills to interact across teams and with stakeholders.