Responsable Pôle Projets Développement Analytique H/F Yposkesi (IDF 91 Corbeil-Essonnes) CDI

Yposkesi recherche un(e) Responsable Pôle Projets Développement Analytique H/F en CDI sur son site de Corbeil-Essonnes (IDF 91).

About YposKesi

• YposKesi is a leading contract development and manufacturing organisation, located in Corbeil-Essonnes (south of Paris, FR) that specialises in gene therapy vectors for the treatment of genetic diseases. Our clients are based worldwide. We have our own development and manufacturing platforms and continue to evolve these through a strong focus on innovation.
  Yposkesi was founded in 2016 with funding from AFM-Telethon (France) and the French state investment bank BPI. We have recently become part of the SK Pharmteco organisation, and continue to grow with a planned doubling of manufacturing capacity (new building, construction underway) in 2023.
• Would you like to join a dynamic and motivated team in this growing therapeutic sector? If so, we are looking for a Head, Analytical Development Projects (Viral vectors).

About the role

• Analytical methods for characterisation and analysis of gene therapy viral vectors are evolving rapidly. A growing Cell and Gene Therapies sector and a rapidly changing regulatory landscape drive a constant evolution in viral vector analytics.
• Based in the Analytical Development group within the Development and Innovation unit, the Head, Analytical Development Projects, will lead a team of analytical Scientists and Project Managers to ensure development and on-time delivery of analytical packages to support progression of our client’s gene therapy viral vector programmes from concept to patient through to the market. This can include full transfer of client analytical methods, development of additional methods, or “plug and play” of the client product/gene in to Yposkesis’ existing analytical platforms for AAV or LV therapeutic vectors.
• The ideal candidate will bring a deep understanding of development and validation of modern analytical methods, with a passion for leading dynamic and high performing teams in an evolving environment (internally, externally). External collaboration with clients and technology partners is an important part of the role. A background in biopharmaceuticals (gene therapy vectors, MAbs, vaccines) at later stages of product development (Phase III, validation, through to submission and commercial launch) is sought.

Key responsibilities

• Lead and support a team of Analytical Scientists and Project managers; continuously clarify priorities, and set clear and meaningful objectives, aligned with company goals;
• Guide the team through the growth and expansion of the company, and through continually evolving client and regulatory expectations;
• Evaluate clients analytical needs, and propose appropriate solutions (method transfer, development, or leveraging of existing internal analytical platform) to ensure clients’ projects can efficiently progress;
• Ensure proactive collaboration with the other functions (e.g., QC, QA, process development, Manufacturing) as part of internal and external CMC Teams supporting client programmes;
• Ensure the seamless transferability of robust and reliable methods to the QC labs to support clinical and commercial release testing;
• Maintain an up-to-date understanding of trends, requirements and regulations in analytical methods for viral vector analysis.

Profile

• PhD in Life Sciences preferred, with a focus on proteins or biochemistry;
• Ideally 5+ years of experience in an applied setting, with experience of working in multi-disciplinary teams;
• Previous experience in management of teams (>3 people), including change management;
• Strong understanding of biological production processes, including (critical) quality attributes, product and process impurities;
• Solid understanding of analytical method development and validation, including regulatory expectations;
• Project management: ability to define a project in steps from initiation to closure, including success criteria, then develop a plan accordingly, track progress versus plan, and clearly communicate this to team and stakeholders;
• Spirit of continuous innovation and improvement;
• Collaboration oriented: ability to understand and appreciate different technical points of view, and align on a path forward. Problem-solving and optimistic approach;
• Client oriented: establishes effective and responsive relationships with clients and internal partners;
•  Strong oral and written English skills (B2-C1 level); intermediate level in French (B1);
• Good understanding of GMPs and the regulatory environment for production of biologics, vaccines, or Advanced Therapeutic Medicinal Products (ATMPs) an advantage.

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