Principal Scientist Immunogenicity

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Division / Function:

Early Development/Clinical Pharmacology DMPK & Pharmacometrics/IMA

Managers 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 Ipsens biologics portfolio. This includes technical supervision and wetlab 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 nonclinical studies.

A high level of scientific rigor autonomy and collaboration is essential. The role requires strong expertise in immunogenicity and immunoanalytical 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 cuttingedge biologics and to collaborate closely with crossfunctional 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 Ipsens 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 (GcLP 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 statusquo 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 multistakeholder environments (CROs internal teams regulators).

Monitor external clinical and nonclinical studies; Assist in the preparation of regulatory documents; Responsible for method development assay transfer and coordination of external GxP validations.

Communicates Effectively

Asks open questions and digs deeper; shows care and respect for different perspectives (both verbally and nonverbally) 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 highquality 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 crossfunctional collaboration (development teams assay groups CROs regulatory early development subteams).

Collaborate closely with crossfunctional 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 performancedriven 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 CROconducted work to ensure compliance and scientific rigor.

Support the transfer and validation for GxPcompliant studies.; Participate in the oversight of analytical methods; Provide technical guidance in protocols and experiments.

HOW - Knowledge & Experience

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 in relevant domains.

• 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 a strong ability to work collaboratively in a dynamic and innovative environment.

Education / Certifications :

• PhD/Postdoc in Immunology or Immunogenicity or at least Masters degree (Bac 5) in Immunology or related field.

Language(s) (preferred):

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

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