Job description
Mission
Join a global team of scientific experts in the Advanced Material Characterization and Investigations (AMCI) group within Analytical Development, where cutting-edge science meets patient impact. As a Scientist in the Advanced Molecular Analysis (AMA) team, you will lead the development and implementation of innovative analytical methods to detect and quantify nitrosamines in pharmaceutical products and complex matrices. You will play a key role in ensuring product safety, supporting regulatory compliance, and driving root cause investigations across the R&D and commercial portfolio.
This is a lab-based role offering the opportunity to work at the forefront of analytical science, using high-resolution mass spectrometry and advanced chromatographic techniques to address one of the pharmaceutical industry’s most critical quality challenges.
Key Responsibilities
* Design, develop, validate, and implement sensitive and robust analytical methods for nitrosamine quantification using LC-MS/MS and HRMS, in compliance with ICH, FDA, and EMA guidelines.
* Conduct and support root cause investigations related to nitrosamine formation, focusing on chemical pathways, impurity profiling, and risk assessment across drug substance and drug product development.
* Perform complex sample preparation and analysis in diverse pharmaceutical matrices, applying expertise in mass spectrometry (Triple Quadrupole, HRMS) and chromatographic separation (UHPLC, GC).
* Collaborate with cross-functional teams (CMC, Process Chemistry, Quality, Regulatory) to provide analytical insights and support timely decision-making.
* Contribute to GMP documentation, method transfer, and regulatory submissions.
* Promote innovation by exploring novel analytical approaches and emerging technologies to enhance detection limits and method robustness.
* Support lab operations in full compliance with GMP, EHS, and data integrity standards.
* Represent AMCI/AMA in internal and external scientific forums; explore collaboration opportunities with academia and research institutions to expand technical capabilities.
Profile Requirements
Education & Experience
* PhD in Analytical Chemistry, Organic Chemistry, or a related field OR Master’s degree with at least 6 years of relevant industry experience.
* Minimum of 4–6 years of hands-on experience in pharmaceutical R&D or analytical services.
* Proven experience in nitrosamine analysis (e.g., NDMA, NDEA) in drug substances, products, or excipients is a strong asset.
* Extensive practical knowledge of mass spectrometry (Triple Quad, Q-TOF, Orbitrap) and chromatography (UHPLC, GC).
* Experience in method development, validation, and transfer under GMP conditions.
* Familiarity with regulatory requirements (ICH Q2, Q3, FDA/EMA guidance on nitrosamines) and GMP principles.
* Excellent English communication skills (written and spoken) for scientific reporting and global collaboration.
Key Competencies
* Scientific curiosity and proactive problem-solving mindset.
* Ability to work independently and as part of a global, multidisciplinary team.
* Strong organizational and time-management skills, with a sense of urgency and focus on delivery.
* Open-minded, adaptable, and committed to continuous learning.
* Results-driven with a passion for innovation in analytical science.
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.