Msat Analytical Technologies Expert H/F - Servier

Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « Engagés pour le progrès thérapeutique au bénéfice des patients ».

Aujourd'hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d'ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.

Nous ? 22 000 passionnés de plus de 50 nationalités, portés par un esprit d'entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l'envie de prendre soin, d'oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.

Venez vivre et contribuez à faire vivre notre engagement #MovedByYou

Within Servier Industry, the Manufacturing Science and Analytical Technology (MSAT) organization plays a key role in driving technical excellence, industrial transformation, and lifecycle management - enabling manufacturing robustness, quality, and compliance across all product modalities and technologies.

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.

Open position in France with domestic and international travel up to 20%

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.