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Analytical Scientist
Il y a 3 mois
Job Title: Analytical Scientist
Location: France
Company: Commercial stage pharmaceutical organisation
Our client is a pioneering pharmaceutical company dedicated to transforming medicine through advanced drug delivery technologies. Our mission is to improve patient outcomes by developing innovative long-acting injectable therapies that provide sustained, controlled release of active pharmaceutical ingredients. Our collaborative and dynamic work environment fosters creativity, scientific excellence, and a commitment to making a real impact on global health.
Position Overview: we are seeking an experienced and highly motivated Analytical Scientist to join our client's R&D team. The successful candidate will play a critical role in the development and characterisation of our innovative drug delivery systems. This position requires a deep understanding of analytical techniques, problem-solving skills, and a passion for scientific discovery.
Key Responsibilities:
- Method Development: Design and develop robust analytical methods for the characterisation and quantification of active pharmaceutical ingredients (APIs) and excipients in various formulations.
- Validation: Conduct method validation in accordance with regulatory guidelines (ICH, FDA, EMA) to ensure accuracy, precision, specificity, linearity, and robustness.
- Sample Analysis: Perform routine and non-routine sample analysis using advanced analytical techniques such as Particle Size Determination, DSC, HPLC, UPLC, GC, LC-MS, NMR, FTIR, and UV-Vis spectroscopy.
- Data Interpretation: Analyse and interpret complex data sets to provide insights into the physicochemical properties of drug formulations and their stability profiles.
- Documentation: Prepare detailed technical reports, method validation protocols, standard operating procedures (SOPs), and regulatory submission documents.
- Collaboration: Work closely with cross-functional teams, including formulation scientists, process engineers, and quality control, to support the development and optimisation of drug delivery systems.
- Troubleshooting: Identify and troubleshoot analytical challenges, providing innovative solutions to support project timelines and objectives.
- Compliance: Ensure all laboratory activities comply with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Qualifications:
- Education: Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field. Candidates with a Master’s degree and 4years relevant experience will also be considered.
- Experience: Minimum of 3-5 years of hands-on experience in an analytical laboratory within the pharmaceutical or biotechnology industry.
- Technical Skills: Proficiency in chromatographic techniques (HPLC, UPLC, GC), Particle Size Determination or DSC or Rheology and spectroscopy methods (LC-MS, NMR, FTIR, UV-Vis). Experience with method development and validation is essential. Knowledge of QbD principals and KF/FT-IR would be a bonus.
- Regulatory Knowledge: Familiarity with regulatory requirements and ICH guidelines for analytical method validation and pharmaceutical development.
- Software: Experience with analytical software and tools such as Empower 3, Morphologi G3, ChemStation, or equivalent.
- Soft Skills: Strong analytical thinking, attention to detail, excellent written and verbal communication skills, and the ability to work effectively in a team-oriented environment.
- Problem-Solving: Demonstrated ability to troubleshoot complex analytical issues and develop practical solutions.
