Senior Bioanalytical Scientist/Principal Bioanalytical Scientist

Senior Bioanalytical Scientist/Principal Bioanalytical Scientist (M/W) Join to apply for the Senior Bioanalytical Scientist/Principal Bioanalytical Scientist (M/W) role at Servier France. Date de parution: 19 nov. 2025Ville: GIF-SUR-YVETTEPays/Région: FRType de contrat: CDIN° offre: 10391 Servier is a human‑sized, independent, international pharmaceutical group governed by a foundation. Our mission is to “Engaged for therapeutic progress for patients.” We are a global leader in cardiology and are expanding into oncology by allocating more than 70% of our R&D budget to difficult‑to‑treat cancers. Our 22,000 passionate employees across 50 nationalities are committed to patient care and teamwork. Main Responsibilities Serve as the primary bioanalytical monitor for outsourced regulated studies. Ensure bioanalytical activities (method validation and sample analysis) are conducted in compliance with FDA, EMA, and ICH guidelines. Review and approve bioanalytical protocols, method validation reports, sample analysis plans, and final reports. Provide scientific oversight of chromatographic‑based bioanalytical methods for quantification of NCEs. Evaluate method development, validation, and sample analysis data for accuracy, precision, and robustness. Troubleshoot analytical issues and provide guidance to CROs and internal teams. Perform or oversee non‑compartmental pharmacokinetic (NCA) analysis. Interpret PK data and contribute to regulatory submissions. Monitor/assess CROs to ensure adherence to GLP/GCP standards. Maintain documentation and records in accordance with internal SOPs and regulatory requirements. Act as a liaison between internal stakeholders (Clinical, non‑clinical Safety, Regulatory & QA) and external partners (CROs). Present bioanalytical and PK data in internal meetings and regulatory submissions. Write/review protocols and scientific reports and prepare appropriate documentation to support applications for regulatory agency filing; provide bioanalytical expertise into related documents such as Investigator Brochures, project strategic documents and study reports. Follow external scientific advances in bioanalysis & pharmacokinetics and promote implementation of relevant technologies & methods internally. Participate in project team meetings as a recognized Bioanalytical expert. Profile Advanced degree (PhD, PharmD, MS) in pharmaceutical sciences, analytical chemistry, biochemistry, or a related field. Minimum of 5 years’ experience in regulated bioanalytical monitoring, preferably in a pharmaceutical or CRO setting. Strong hands‑on experience with LC‑MS/MS for small molecules. Proficiency in non‑compartmental pharmacokinetic analysis and relevant software tools. In‑depth knowledge of GLP, GCP, ICH M10, and other regulatory guidelines. Preferred Skills (Bonus) Prior involvement in regulatory submissions (IND, NDA, BLA). Familiarity with ligand‑binding assays or platforms such as Gyrolab and MSD. Understanding of immunogenicity assay development and validation. Experience working on multiple drug modalities (NCEs, NBEs, ASOs) is a plus. Excellent organizational, communication, and problem‑solving skills. Ability to work independently to drive projects forward as well as collaboratively in a multidisciplinary team (matrix) environment. Demonstrated ability to lead projects, mentor junior scientists, and effectively communicate complex scientific concepts. 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. #J-18808-Ljbffr