Principal Scientist - Immunogenicity

Ipsen Pharma (SAS); Paris; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global biopharmaceutical company in France is seeking a Principal Scientist in Immunogenicity to oversee immunogenicity development for biologics. You will lead laboratory efforts, ensure compliance with regulatory standards, and contribute to documentation. The ideal candidate has over 5 years of experience in the pharma/biotech industry, a PhD/Postdoc in Immunology, and proficiency in English and French. This role requires strong collaboration and scientific oversight skills.

Qualifications

• 5+ years in pharma/biotech focused on immunoassays and ADA detection.
• Proven experience developing immunoassays and cell‑based assays.
• Knowledge of GLP/GxP standards and managing CROs.

Responsabilités

• Lead immunogenicity development activities for biologics.
• Provide scientific oversight to laboratory initiatives.
• Draft and review regulatory documentation.

Connaissances

Immunoassays development

ADA detection

Scientific oversight

Method validation

Regulatory documentation

Collaboration

Formation

PhD/Postdoc in Immunology

Master’s degree in Immunology

Outils

ELISA

ECLA

CBA

LBA

Description du poste

Title: Principal Scientist - Immunogenicity

Company: Ipsen Innovation (SAS)

Location: Dreux Laboratories

About Ipsen:

Ipsen is a mid‑sized global biopharmaceutical company with a focus on transformative medicines in 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 culture of collaboration, excellence, and impact.

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, including technical supervision, wet‑lab contribution, method development, assay transfer, and coordination of external GxP validations. The position also encompasses drafting and reviewing regulatory documentation and overseeing clinical and non‑clinical studies.

Main Responsibilities & Technical Competencies

Technical Leadership

• Provide technical guidance and scientific oversight to the laboratory team in developing protocols, executing experiments, and interpreting results.
• Develop and optimize immunoassay and immunogenicity methods (ELISA, ECLA, CBA, LBA, etc.) for Ipsen’s asset portfolio.
• Explore and implement innovative technologies and platforms.
• Occasionally contribute to wet‑lab activities to support method development or technology implementation.

Method Transfer & Validation

• Support the transfer and validation of in‑house‑developed methods to CROs for GxP‑compliant studies.

Documentation & Regulatory Support

• Contribute to drafting and reviewing clinical study documentation: protocols, CSR, SAP, SMP, DTP, Lab Manual, 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 (GCLP, GLP, non‑GLP) conducted at CROs.
• Participate in 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 Required

• Cultivate Innovation – Question status‑quo, adopt new approaches, envision new possibilities, think outside the box, integrate diverse perspectives.
• Manage Complexity – Identify contradictory information, evaluate alternative scenarios, prioritize impactful decisions, navigate complex datasets and regulatory expectations.
• Communicate Effectively – Ask open questions, communicate transparently, build clear messages, use visual communication and storytelling.
• Collaborate – Remove organizational barriers, leverage cross‑functional collaboration, support regulatory and CRO engagements.
• Excellence in Execution – Set clear goals, allocate resources, meet timelines, focus on performance‑driven KPIs.

Knowledge & Experience

• 5+ years in the pharma/biotech industry focused on immunoassays and ADA detection, or at least 3 years in a CRO environment.
• Proven experience developing immunoassays and cell‑based assays (CBA, ECLA, ELISA, LBA).
• Knowledge of GLP/GxP standards and experience managing external partners/CROs.
• Ability to contribute to regulatory documentation.
• Understanding of DMPK requirements for regulatory submissions (IND, IB) and clinical study execution.
• Demonstrated scientific rigor, autonomy, and collaborative mindset.

Education / Certifications

• PhD/Postdoc in Immunology or Immunogenicity, or at least a Master’s degree in Immunology or a related field.

Language(s)

• Strong proficiency in written and spoken English and French is required.

We are committed to creating a workplace where everyone is heard, valued, and supported. We value diverse perspectives and experiences. If you need accommodations during the application process, please inform our recruitment team. This information will be handled with care and will not affect your application outcome.