Role Overview
As a Senior Analytical Scientist you will lead the development optimization and implementation of robust analytical methods using UPLC/HPLC systems. Your expertise will directly support development projects by ensuring data integrity compliance and adherence to regulatory standards.
Key Responsibilities
- Analytical Method Development: Design and conduct experiments to create reliable chromatographic methods employing risk assessment and QualitybyDesign (QbD) principles when applicable.
- Data Analysis: Compile interpret and present scientific data to guide decisionmaking and ensure method robustness.
- Project Management: Oversee experiments and ensure timely completion either independently or by coordinating with team members.
- Documentation & Compliance: Develop validate and document chromatographic methods in alignment with company quality standards and ICH guidelines.
- Technical Writing: Write update and review SOPs related to equipment use and analytical procedures.
- Collaboration: Actively collaborate with crossfunctional teams such as R&D regulatory affairs and process development to meet project objectives.
- Knowledge Transfer: Support the transfer of analytical methods to internal teams or external partners (e.g. CDMOs).
- Continuous Improvement: Drive lab process improvements adopt best practices and expand analytical capabilities by evaluating new technologies.
- Client Interaction: Participate in client meetings and teleconferences effectively communicating in English.
Qualifications
- MSc in Analytical Chemistry Chemistry or a related field with at least 5 years of experience in UPLC/HPLC method development and prevalidation within an R&D setting.
- Proficient in using Empower3 software.
- Knowledge of DoE methodologies (e.g. SMatrix Fusion QbD or similar software) is advantageous.
- Familiarity with QbD principles for analytical method development and validation is a plus.
- Understanding of complementary analytical techniques particularly mass spectrometry (MS) is desirable.
- Experience working in GMP/GLPcompliant environments and knowledge of ICH guidelines is an asset.
Key Competencies
- Strong scientific curiosity and analytical expertise.
- Handson experience with analytical instrumentation and methods.
- Proficiency in basic statistical analysis and experimental design.
- Problemsolving skills and the ability to make sound technical decisions.
- Excellent organizational and project management capabilities.
- Effective written and verbal communication skills in English; proficiency in French is a strong advantage.
- Familiarity with writing scientific documents and working in an international environment is preferred.
- Crossborder educational or professional experience is a plus.