We are looking for an analytical scientist to join our Spectroscopy/Spectrometry unit based Montpellier, to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.
As the analytical scientist in the Spectroscopy/Spectrometry unit you will be responsible for the design of experiments, data generation and interpretation to perform Spectroscopy/Spectrometry method development, validation or transfer. You will also be responsible for the design of regulatory stability studies and the generation of regulatory stability data and QC testing data of regulatory and clinical batches.
Responsibilities & Duties
- Perform literature research to define design space of the method development
- Process raw data and analyze test results during method development, based on sound scientific conclusions and decisions
- Propose method validation strategy, design method validation pathway and implement method validation in adherence to internal and ICH guidelines
- Identify analytical procedures bottlenecks and implement the appropriate changes in accordance with change control process
- Define and optimize the periodic equipment maintenance or calibration
- Perform experiments, compile, analyze and interpret data to achieve a robust and fit-for-purpose method
- Perform spectroscopic method development, validation and transfer within the appropriate Quality framework in adherence with company quality management system
- Implement tracking and management of deviations and changes during method development, validation and transfer. Lead deviation management, impact assessment and action plan definition, as well as change control management.
- Implement risk assessment and QbD analytical method development approach in the projects, whenever possible
- Coordinate and ensure successful timely completion of experiments with the support of lab technicians
- Provide training to end-users
- Represent the Analytical Center of Expertise within assigned Product Development & Supply Team(s), coordinating all analytical activities (chromatographic, spectroscopic and Physico-chemical)
- Document the method development or validation work in protocols, development reports, validation reports and transfer reports
- Write/update or review SOPs related to equipment use and analytical procedures
- PhD or MSc in Analytical Chemistry or Chemistry
- Minimum 3 years’ experience in LC-MS, LC-MS/MS and LC-UV
- Experience on structural elucidation with HRMS
- Experience in MALDI-TOF will be appreciated
- Experience in others spectrometric and spectroscopic techniques as UV-visible, FTIR and RAMAN analysis
- Confident Empower and MassLynx® software user
- Experience of working under GMP/GLP and ICH Guidelines