MSAT Analytical Technologies Expert (Cardio-Metabolism)

MSAT Analytical Technologies Expert (Cardio-Metabolism) Servier Suresnes, France Role Summary Reporting to the MSAT Analytical Technology Lead - CMVD Products, you will serve as an analytical subject matter expert (SME) for commercial CMVD products. You will be responsible for the analytical method lifecycle management, method transfers, validations, verifications and troubleshooting at external and internal manufacturing/testing sites, as applicable. Primary Responsibilities Analytical point of contact responsible to provide analytical oversight of raw materials to active pharmaceutical ingredients (APIs) and various Oral Dosage forms (e.g., tablets, capsules, suspensions) manufactured at external CMOs and support site-based MSAT Analytical teams if applicable. Responsible for the method transfers to external/internal sites to support CMVD APIs and Products manufacturing. Responsible for analytical life cycle management (method development, validation, control strategy, transfers, release and stability testing) at the CMO. Responsible to collaborate with the internal sites, as required, to support the analytical life cycle management of the Servier products. Manage and review deviation events and OOS/OOT investigations at CMOs and internal sites in coordination and collaboration with QA/QC team. Support regulatory filling - author/review CMC-related sections for regulatory filings for the new markets and work with regulatory to respond to regulator's inquiries. Represent analytical function in project team meetings and work closely with cross-functional teams to meet project timelines and goals. Actively participate in internal virtual plant team and joint technical team meetings. Education Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry or Medicinal Chemistry or related discipline with 5 years of relevant experience, a Master's degree with 7 years of relevant experience working in the Oral Dosage products. Technical Skills In-depth theoretical and extensive hands-on experience in various analytical techniques and instrumentations. Experienced in solid-state analysis, physical characterization, and drug product dissolution. Prior experience in the comparative quality assessment i.e. In vitro comparative quality assessment of different brands of CMVD modified release tablets and capsules. Strong background in method development, validation, and routine analysis for Nitrosamine impurities in drug product test samples. Knowledge of industry USP/ICH guidance for the development, qualification/validation of analytical methods. Previous experience in drafting and reviewing analytical sections of regulatory submissions, including new and post-approval changes (MAA/NDA and Variations), as well as responding to health authority queries. Experience in use/application of basic statistical methodologies and software s (e.g., Minitab, JMP or equivalent). Soft skills Excellent organizational skills: Proactive, management of multiple tasks of varied complexity simultaneously. Excellent communications and presentation skills written and verbal. Good listening and writing skills in English. Ability to work in a team-oriented environment that embraces change, risk, and flexibility. Apply Now