Senior Bioanalytical Scientist - Principal Bioanalytical Scientist M - W H/F - Servier

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www.servier.comWe are seeking a highly enthusiastic, self-motivated senior scientist/principal scientist with bioanalytical and pharmacokinetics knowledge of New Chemical Entities (NCEs) for a position as a bioanalytical project representative & preclinical PK expert. The bioanalytical and non-clinical PK group encompasses broad scientific expertise in mass spectrometry, metabolomics, ligand binding assays, regulated bioanalysis, and pharmacokinetics. The successful candidate will work within a team of bioanalytical scientists that collaborate across many disciplines within Research and Development. The ideal candidate will have deep expertise in LC-MS methodologies and non-compartmental pharmacokinetics, ensuring compliance with regulatory standards (e.g., GLP, GCP) and scientific integrity throughout the bioanalytical lifecycle.

The bioanalytical and non-clinical PK group sits in the Drug Metabolism and Pharmacokinetics (DMPK) department, which in turn is a key member of translational medicine. The role requires an in-depth knowledge of innovative and fit-for-purpose approaches in the field of bioanalysis and pharmacokinetics. The candidate is expected to promote, design, communicate, and execute the relevant approaches in projects from the therapeutic areas of interest for the Servier group (Oncology and Neurology & immuno-inflammation mainly). This is a strategic role as well as a scientific and technical role, as it includes coordination of laboratory-based activities. This is a full-time position at our new R&D center in Paris -Saclay with some home-based work (up to 8 days per month). The position is an individual contributor role, which will not involve direct line reports. The position will report directly to the Head of Bioanalysis and Non-Clinical PK at the Saclay site in Paris.

Main Responsibilities :

The successful applicant will be primarily responsible for the following:

- Serve as the primary bioanalytical monitor for outsourced regulated studies.
- Ensure bioanalytical activities (method validation and sample analysis) are conducted in compliance with applicable regulatory guidelines (FDA, EMA, ICH).
- 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 (e.g., Clinical, non-clinical Safety, Regulatory & QA) and external partners (e.g., 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 and implement relevant technologies & methods internally to ensure state-of-the-art lab capabilities and continuous support for projects.
- Participate in project team meetings as a recognized Bioanalytical expert

Profile :

Advanced degree (PhD, PharmD, MS) in pharmaceutical sciences, Analytical Chemistry, biochemistry, or 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 project forward as well as collaboratively in a multidisciplinary team (matrix) environment.
- Demontrated 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.