CMC PROJECT MANAGER

Yposkesi sas, an SK Pharmteco company, is one of Europe’s largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy and viral vector manufacturing.

A one-stop shop for biotech and pharmaceutical companies seeking to advance clinical trials and commercialize new Advanced Therapy Medicinal Products (ATMPs).

Yposkesi’s is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France.

We are currently looking for a new “ CMC Project Manager”, are you ready to join the exciting field of Gene therapy ?

About the role

Reporting to the Director of project management, the Project Manager ensure the management of client CMC projects with a constant objective of profitability and customer satisfaction, in compliance with the commitments made, the allocated budget and the regulatory requirements.

Key responsabilities

• Responsible for leading multi-disciplinary teams, including process development, analytical development, operations, quality assurance involved in viral vector manufacturing projects according to customer request for Services.
• To be the key interface between Business Development, Operations and the customer.
• Support proposal team for elaboration of technical proposal offer for customers
• Promote and establish Change Order for ongoing projects
• Lead and coordinate project progress (consolidate key project milestones, budgets, project load plans and risks).
• Responsible for the preparation of reports and communicate project progress to stakeholders and management.
• Manage KPIs to anticipate potential drifts and negotiate, with contributing departments, alternative solutions to ensure compliance with commitments.

Profile

• Bachelor’s degree in engineering or a life sciences field with 5+ years of relevant project management experience required in pharmaceutical or biotechnology.
• Minimum of 3 years of experience with direct involvement in the CMC area, including Analytical Development, Process Development or Bioproduction in biologics manufacturing.
• Good understanding of GMPs and the regulatory environment.
• Client oriented: establishes effective and responsive relationships with clients.
• Leadership and motivational skills to engage and influence key stakeholders both cross functionally and at ranging levels of seniority (with both internal and external partners).
• Ability to lead successfully in a dynamic matrix environment and to manage multiple priorities while driving all projects forward and meeting project deliverables.
• Solutions orientated and capable of making crucial decisions under pressure
• Strong oral and written English skills (B2-C1 level)