Principal Scientist

Overview The Immunogenicity Principal Scientist is a key contributor within the Immunogenicity & Immunoanalysis team in the Clinical Pharmacology, DMPK & Pharmacometrics department. The role is responsible for leading and contributing to immunogenicity and immunoassay development activities that support Ipsen’s biologics portfolio. This includes technical supervision and wet‑lab contribution, support to method development, assay transfer, and coordination of external GxP validations. The position also encompasses the drafting and review of regulatory documentation and oversight of clinical and non‑clinical studies. A high level of scientific rigor, autonomy, and collaboration is essential. The role requires strong expertise in immunogenicity and immuno‑analytical method development, along with proven experience working with external partners (CROs) and contributing to regulatory dossiers. This position provides the opportunity to work at the forefront of immunogenicity and immunoanalysis science, to support the development of cutting‑edge biologics, and to collaborate closely with cross‑functional teams in a dynamic and innovative environment. Responsibilities Technical Leadership Provide technical guidance and scientific oversight to the Immunogenicity & Immunoanalysis laboratory team (scientist/postdoc fellow) in the development of protocols, execution of experiments, and interpretation of results for laboratory activities conducted in Dreux Develop and optimize immunoassay and immunogenicity methods (ELISA, ECLA, CBA, LBA, etc.) in support to Ipsen’s asset portfolio Explore and implement innovative technologies and platforms. Occasionally contributes to wet lab activities to support the team in the development of analytical methods or the implementation of innovative technologies. Method Transfer & Validation Support the transfer and validation of in‑house‑developed methods to CROs for GxP‑compliant clinical and non‑clinical studies. Documentation & Regulatory Support Contribute to the drafting and review of clinical study documentation, including protocols, CSR, SAP, SMP, DTP, Lab Manual, and IOP. Assist in the preparation of regulatory documents (IND, IB, Immunogenicity Risk Assessment). Support responses to regulatory authority queries. Study Oversight Monitor external clinical and non‑clinical studies (GCPL, GLP, non‑GLP) conducted at CROs. Participate in the oversight of analytical methods, validation reports, and associated sample analysis results when integrating new assets. Strategic Contributions Participate in due diligence evaluations for new biological entities. Represent the function in project teams (Early Development subteam). Behavioural Competencies Cultivate Innovation: questions status‑quo, adopt new approaches, vision, ideas into actions, out‑of‑box thinking, integrates diverse perspectives. Manage Complexity: identify conflicting information, evaluate alternatives, prioritize impact, navigate complex datasets, regulatory expectations, and stakeholder environments. Communicate Effectively: asks open questions, respects perspectives, transparent, clear messaging, uses visual communication, demonstrates gravitas. Collaborate: remove barriers, continuous improvement, resourceful, entrepreneurial mindset. Excellence in Execution: prioritize, set clarity on goals, timelines, KPIs, plan resources, share best practice. Knowledge & Experience 5+ years in pharmaceutical/biotech industry with a focus on immunoassays and ADA detection, or at least 3 years in a CRO environment. Proven experience in developing immunoassays and cell‑based assays (CBA, ECLA, ELISA, LBA) in immunoanalysis and Immunogenicity. Knowledge of GLP/GxP standards and experience in the management of external partners/CROs. Ability to contribute to the preparation of regulatory documentation. Understanding of DMPK requirements for regulatory submissions (IND, IB) and clinical study preparation/execution. Demonstrated scientific rigor, autonomy, and strong collaborative ability in a dynamic and innovative environment. Education / Certifications PhD/Postdoc in Immunology or Immunogenicity or at least Master’s degree (Bac +5) in Immunology or related field. Languages Strong proficiency in written and spoken English and French is required. #J-18808-Ljbffr