As a Scientist, you will join the Advanced Material Characterization and Investigations (AMCI) group within the Analytical Development (AD) department. AMCI is an international and diverse team focused on advanced analytical characterization of pharmaceutical products and leading global analytical investigations.
Within AMCI, you will be part of the Advanced Molecular Analysis (AMA) team, a center of excellence in structure elucidation (high-resolution mass spectrometry and NMR), trace analysis, polymer characterization, and analytics for ADCs, oligonucleotides, and peptides.
In this role as Scientist (Project Owner), you will play a key role in designing and coordinating experiments to quantify nitrosamine impurities across various matrices and pharmaceutical products. The position combines laboratory work with project coordination and close collaboration with internal and external partners.
Key Responsibilities
- Design and coordinate analytical methods for nitrosamine quantification, including sample preparation, chromatographic separation, and detection, in compliance with regulatory guidelines and company standards
- Review protocols and reports from internal and external laboratories
- Collaborate with internal and external partners to ensure right-first-time execution
- Represent the AMA team in cross-functional project teams
- Translate project needs into analytical deliverables (development, characterization, batch support)
- Communicate and discuss results with subject matter experts and project teams
- Lead analytical investigations and deviation management
- Ensure compliance with GMP, safety, and quality standards
Qualifications
Education & Experience
- PhD in analytical chemistry, pharmaceutical sciences, or a related field or a Master’s degree with at least 6 years of relevant experience
- Experience in pharmaceutical R&D is an asset
- Strong planning and organizational skills, with the ability to manage multiple projects
- Knowledge of GMP and industrial practices is a strong advantage
- Experience with nitrosamine analysis is highly desirable
- Expertise in mass spectrometry (e.g., Triple Quadrupole, HRMS)
- Experience in chromatographic method development is a plus
- Familiarity with regulatory frameworks (ICH, EMA, FDA) and validation requirements is an advantage
- Excellent English communication skills (written and spoken)
Competencies
- Curious, fast learner, proactive and self-driven
- Strong team player in a global environment
- Effective communication and presentation skills
- Flexible, dynamic, and results-oriented
- Strong sense of urgency and accountability
What We Offer
- A challenging role in a leading global pharmaceutical company
- Collaboration with top scientists in an innovative environment
- Opportunities for personal and professional growth
- A balanced role combining laboratory work and project coordination
Solliciteren