Principal Scientist - Immunogenicity

Cookie Notice**Title:**Principal Scientist - Immunogenicity**Company:**Ipsen Innovation (SAS)**About Ipsen:**Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.

S., France and the U.

K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at and follow our latest news on and .**Job Description:**## **Division / Function:**## Early Development/Clinical Pharmacology, DMPK & Pharmacometrics/IMA## **Manager’s Job Title:**## Director Immunogenicity and Immunoanalysis## **Ipsen Job Profile:**## Principal Scientist## **Location:**## Dreux Laboratories## ## ## **WHAT -** **Summary & Purpose of the Position**## 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 Gx

P 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.## ## **WHAT -** **Main Responsibilities & Technical Competencies**## **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 Gx

P-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 (Gc

LP, 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).## ## **HOW

• Behavioural Competencies Required**## **Competency**## **Competency Behavioural Markers**## **Explanation of Choice**## **References to Job Description**## Cultivate Innovation##

• Questions status‑quo and adopt new approaches Has vision, bring ideas and possibilities and turn it into actions Thinks outside the box, reframes problems in different lights Encourages/considers/integrates different perspectives/ideas## Innovation is essential when optimizing and developing immunoassays, troubleshooting complex experimental challenges, and implementing emerging analytical technologies critical for biologics programs.## Explore and implement innovative technologies and platforms.; Develop and optimize immunoassay and immunogenicity methods…; This position provides the opportunity to work at the forefront of immunogenicity and immunoanalysis science.## Manage Complexity## Identifies contradictory information/demands/inputs to effectively solve problems Develops and evaluates alternative scenario and solutions Able to identify what truly matters and ruthlessly focus/prioritize on making decisions with real impact## The role requires navigating complex datasets, regulatory expectations, assay performance issues, and multi‑stakeholder environments (CROs, internal teams, regulators).## Monitor external clinical and non‑clinical studies…; Assist in the preparation of regulatory documents…; Responsible for method development, assay transfer, and coordination of external Gx

P validations.## Communicates Effectively##

• Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and non‑verbally) and able to relate to other points of view Communicates transparently, “tells it how it is” while keeping the communication respectful Builds clear and crisp messages with structure and focus, uses visual communication and storytelling to make the message easy to digest and connect with the outcomes Demonstrates gravitas## Clear communication is critical for drafting regulatory documentation, guiding CROs, supervising internal staff, and ensuring high‑quality study oversight.## Contribute to the drafting and review of clinical study documentation…; Support responses to regulatory authority queries.; Provide technical guidance and scientific oversight…## Collaborates## Collaborates and communicates without boundaries, continuously removes organizational barriers Focuses on continuous improvement; integrates and leverages key learnings, showcases resourcefulness, learning/experimenting at scale, demonstrates strong entrepreneurial behaviors and mindset## Success requires strong cross‑functional collaboration (development teams, assay groups, CROs, regulatory, early development subteams).## Collaborate closely with cross‑functional teams…; Represent the function in project teams…; Support the transfer and validation to CROs.## Excellence in Execution## Approaches priority setting and setting the stage through the lens of execution Establishes clarity about the goals, accountabilities, timelines, and next steps; can identify/spot opportunities for real impact on patient and society Able to be focused and performance‑driven with clear KPIs Plans and aligns effectively (steps, resources, timelines etc.) Displays a commitment to best practice sharing and setting Promotes single point of accountabilities.## The position requires precise execution of immunogenicity studies, regulatory documentation, method validation, and oversight of CRO‑conducted work to ensure compliance and scientific rigor.## Support the transfer and validation for Gx

P‑compliant studies.; Participate in the oversight

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