2 months ago
Principal Scientist (Bioanalytics)
5 063 - 7 088€
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Job description
Text:
TL;DR
Principal Scientist (Bioanalytics): Developing and optimizing bioanalytical methods for mRNA-LNP products with an accent on potency assays, Flow Cytometry, and ELISA. Focus on transferring pre-validated methods to GMP-compliant Quality Control departments and serving as a Subject Matter Expert for internal and external stakeholders.
Location: Geleen, Netherlands
Salary: €60,750–€85,050
Company
A global leader in life sciences dedicated to manufacturing the medicines of tomorrow across 30+ sites worldwide.
What you will do
- Transfer, optimize, and develop bioanalytical methods to support product development and quality control.
- Plan, execute, and document method pre-validation studies in accordance with regulatory requirements.
- Author Standard Operating Procedures (SOPs) and provide technical support for cross-departmental validation documents.
- Train colleagues and transfer pre-validated methods to the GMP-compliant Quality Control (QC) department.
- Perform routine testing for development campaigns and stability studies.
- Act as a Subject Matter Expert (SME) during interactions with internal stakeholders and external clients.
Requirements
- PhD and multiple years of experience in analytical development.
- Expertise in analytical development of Bioassays specifically for mRNA-LNP.
- Practical experience in potency assays according to ICH and USP guidelines, with a focus on Flow Cytometry (FACS) and ELISA.
- Deep understanding of statistical methods relevant to analytical method development and validation.
- Practical experience with aseptic cellular handling.
- Ability to lead and develop junior staff.
Nice to have
- Experience with GMP-compliant documentation and laboratory practices.
- Theoretical and hands-on experience with Sanger Sequencing, Oxford Nanopore, qPCR, or LC-MS.
- Initial experience in project or customer management within an analytical development environment.
Culture & Benefits
- Agile career opportunities within a dynamic and inclusive working culture.
- Compensation programs designed to recognize high performance.
- Access to a variety of global benefits dependent on role and location.
- Ethical workplace emphasizing collaboration, accountability, and integrity.
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