R&D Analytical Methods Scientist Pharmaceuticals F/M/X
Listed on 2026-01-16
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Research/Development
Research Scientist, Data Scientist -
Healthcare
Data Scientist
Location: Town of Belgium
Purpose of the Role
Senior Scientist in Analytical Method Development is a scientific leader responsible for driving the design, execution, and lifecycle management of robust analytical methods to support drug development, process optimization, and regulatory compliance. The role ensures the development and pre‑validation of cutting‑edge analytical techniques while mentoring junior staff, leading cross‑functional projects, and aligning scientific strategy with business objectives. The incumbent serves as a subject‑matter expert (SME) for complex analytical challenges and contributes directly to regulatory submissions and innovation initiatives within a highly regulated environment.
KeyAccountabilities
Analytical Method Development & Pre‑Validation
- Lead end‑to‑end development and pre‑validation of complex analytical methods (e.g., HPLC, ELISA, CE, Mass Spectrometry) for drug substances and products.
- Serve as SME for advanced analytical technologies, providing strategic guidance to project teams and stakeholders.
- Design experimental plans (e.g., DOE) to optimize method robustness, specificity, and reproducibility.
Documentation & Regulatory Compliance
- Author and review technical protocols, validation reports, SOPs, and regulatory submission documents (e.g., product dossiers).
- Ensure 100% compliance with GxP regulations, data integrity standards (ALCOA+), and internal quality systems.
- Write and review GxP documentation (deviations, change controls) and proactively address compliance issues.
Data Analysis & Scientific Rigor
- Analyze complex datasets using statistical tools (e.g., Minitab, JMP) to derive actionable insights.
- Present findings clearly to stakeholders via reports, presentations, and technical reviews.
- Uphold scientific rigor through reproducible methodologies and critical evaluation of results.
Project & Stakeholder Leadership
- Manage complex analytical projects from scoping to delivery, including timelines, resources, and risk mitigation.
- Represent analytical development in cross‑functional teams (R&D, QC, QA, Manufacturing) to align priorities.
- Influence strategic decisions through data‑driven recommendations and innovation leadership.
Laboratory Excellence & Innovation
- Oversee method development/pre‑validation activities in laboratory settings.
- Support equipment qualification, calibration, and 5S/continuous improvement initiatives.
- Drive adoption of emerging technologies (e.g., AI/ML in data analysis) to enhance method efficiency.
Talent Development & Knowledge Sharing
- Mentor Scientists, Associate Scientists, and Lab Technicians through technical guidance and career coaching.
- Lead onboarding, training, and competency development for analytical techniques and GxP compliance.
- Promote scientific curiosity via literature reviews, conference participation, and internal knowledge sessions.
- Master’s degree or PhD in Biotechnology, Biochemistry, Pharmaceutical Sciences, Chemistry, or related field.
- 7+ years in analytical method development within pharmaceutical/biotechnology R&D.
- Full lifecycle management experience (development → pre‑validation → transfer).
- Direct experience with regulatory submissions (e.g., EMA/FDA).
- Leadership of cross‑functional projects.
- Deep understanding of ICH Q2(R1), GMP, GLP, and data integrity requirements.
- Advanced proficiency in HPLC/UPLC, CE, Mass Spectrometry, ELISA, UV‑Vis, and related techniques.
- Method validation (specificity, accuracy, precision, robustness).
- Statistical analysis tools (Minitab, JMP, Design‑Expert®).
- Expertise in analytical method transfer and lifecycle management.
- Troubleshooting complex instrumentation and method failures.
- GxP documentation (protocols, reports, deviations, change controls).
- Proven leadership in high‑stakes project environments with matrixed teams.
- Exceptional written and spoken communication skills in English; fluency in French and/or Dutch preferred.
- Solution‑oriented mindset with the ability to simplify complex scientific concepts.
- Strong organizational skills to manage competing priorities in dynamic settings.
- Commitment to mentoring, collaboration, and continuous improvement.
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.
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