Carry out biochemical and immunological analyses for product release and stability studies. Contribute to method validation, lead improvement projects and support colleagues. Requires HLO education in Biochemistry or Life Sciences and at least eight years of pharmaceutical GMP experience.
The role
As a Senior Biochemistry Analyst, you are responsible for the progress and execution of analytical tests on samples of raw materials, intermediates and finished products. These tests support product release and stability studies. You work with biochemical and immunological methods, including ELISA, HPLC, SDS electrophoresis and immunoblotting. The position is based in Leiden, in the province of South Holland.
Responsibilities
- Work in accordance with GMP and GLP guidelines.
- Perform analytical tests for product release and stability studies, as well as general laboratory work.
- Contribute to the validation of analytical methods.
- Lead improvement projects in the laboratory together with a group of analysts.
- Troubleshoot assays and act as the first point of contact for the development team.
- Independently assess analytical results and report deviations to the responsible manager.
- Accurately process and report analytical results in LIMS.
- Write, revise and improve documents using the pharmaceutical documentation system.
- Prepare clear project reports, including trend reports.
- Train new colleagues and keep your professional knowledge up to date.
Requirements
- Completed HLO-level laboratory education in Biochemistry or Life Sciences.
- At least eight years of experience in the pharmaceutical industry in a GMP environment.
- Extensive experience performing and/or validating ELISA assays and/or HPLC.
- Experience with GMP-related quality systems, including deviations and change control.
- Good spoken and written Dutch and English.
- Ability to work independently and as part of a team.
- A proactive and flexible approach to work.
- Good planning and coordination skills.
- Ability to guide colleagues and involve them in the team.
What is offered
You will work in a dynamic and interesting environment. The package includes a competitive salary, a 13th-month payment, 30 days of annual leave, and contributions towards a pension and health insurance.