Job description
Mission Overview::
As a Scientist, you will play a key role in designing, coordinating, and executing analytical strategies to quantify nitrosamine impurities in various matrices and pharmaceutical products.
This position combines office and laboratory work, leveraging your expertise in chemistry and mass spectrometry to:
* Design analytical tests and methods
* Coordinate activities with internal and external laboratories
* Lead and support root cause investigations
* Explore innovative analytical approaches
You will collaborate closely with internal specialists and cross-functional teams to ensure robust, compliant, and state-of-the-art analytical solutions that support Janssen’s commercial and R&D portfolio.
Key Responsibilities
* Method Development & Coordination
o Design and coordinate the development of analytical methods for the quantification of nitrosamines, from innovative sample preparation to advanced chromatographic separations and detection.
o Ensure methods are aligned with regulatory guidelines and internal company standards.
o Coordinate analytical activities in internal and external laboratories, ensuring right-first-time execution.
* Documentation & Review
o Review and approve analytical protocols and reports from internal and external laboratories.
o Ensure high-quality documentation in line with GMP and regulatory expectations.
* Project Ownership & Cross-functional Collaboration
o Represent the AMA team in cross-functional project teams together with the analytical project leader and other analytical functions.
o Translate project needs into clear analytical deliverables (e.g., development, characterization, batch overview support).
o Communicate, discuss, and report test results to experts and cross-functional product teams.
* Investigations & Compliance
o Lead analytical investigations and deviations related to nitrosamine and other relevant analytical topics.
o Ensure compliance with all relevant regulations, GMP and safety requirements.
o Contribute to continuous improvement of analytical strategies and workflows.
Profile Requirements
Education & Experience
* PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field;
or Master’s degree in a related science with minimum 6 years of relevant experience.
* Work-related experience in pharmaceutical R&D is a strong asset.
* Practical experience in industry and knowledge of GMP regulations are strong assets.
* Proven expertise in nitrosamine determination in pharmaceutical products is a clear advantage.
* Demonstrated experience in mass spectrometry, including:
o Triple Quadrupole
o High-Resolution MS (LC-HRMS)
* Familiarity with chromatographic method development (e.g., LC) is preferred.
* Knowledge of regulatory frameworks (e.g., ICH, EMA, FDA) and GMP guidelines, particularly regarding validation requirements, is an advantage.
* Excellent English communication skills, both written and spoken, enabling effective scientific discussion and collaboration in a global environment.
Competencies
* Fast learner with strong scientific curiosity; self-steering, proactive, and creative.
* Open-minded, collaborative, and able to work effectively as one team in a global environment.
* Strong written and oral communication and presentation skills in English.
* Efficient, flexible, dynamic, and results/performance-driven.
* Strong planning and tracking skills; well organized and capable of handling multiple projects and priorities.
* Demonstrated sense of urgency and ownership in delivering high-quality results.
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.