CMC Project Manager

TN France; Corbeil-Essonnes; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An innovative firm in the biotech sector is seeking a dynamic CMC Project Manager to lead exciting projects in gene therapy. This role involves managing multi-disciplinary teams, ensuring project profitability, and maintaining customer satisfaction. With a focus on compliance and regulatory requirements, the successful candidate will engage with clients and stakeholders, driving progress and overcoming challenges. Join this forward-thinking organization and contribute to the advancement of cutting-edge therapies that make a real difference in patients' lives.

Qualifications

• 5+ years of project management experience in pharma or biotech.
• Strong understanding of GMPs and regulatory requirements.

Responsabilités

• Lead multi-disciplinary teams in viral vector manufacturing projects.
• Prepare reports and communicate project progress to stakeholders.

Connaissances

Project Management

Leadership

Client Relationship Management

Problem Solving

GMP Knowledge

Communication Skills

Formation

Bachelor's degree in Engineering or Life Sciences

Description du poste

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Yposkesi, an SK pharmteco company, is one of Europe’s largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy 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 offers a full range of services in lentiviral vectors and AAV (Adeno-Associated Virus) cGMP manufacturing. Yposkesi is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France, and currently employs approximately 200 persons.

Description

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

About the role :

Reporting to the Director of CMC Project Management, the CMC Project Manager will ensure the management of CMC projects with the goal of profitability and customer satisfaction, in compliance with commitments, budget, and regulatory requirements.

Key responsibilities :

• Lead multi-disciplinary teams, including process development, analytical development, operations, and quality assurance involved in viral vector manufacturing projects according to customer requests for services.
• Serve as the key interface between Business Development, Operations, and the customer.
• Support the Sales team in preparing commercial proposals for new customers.
• Lead and coordinate project progress, including consolidating key milestones, budgets, load plans, and risks.
• Prepare reports and communicate project progress to stakeholders and management.
• Manage indicators to anticipate potential issues and negotiate solutions with departments to ensure commitments are met.

Minimum qualifications :

• Bachelor’s degree in engineering or a life sciences field with 5+ years of relevant project management experience in pharmaceutical or biotechnology sectors.
• At least 3 years of 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 stakeholders at various levels.
• Ability to lead in a dynamic matrix environment and manage multiple priorities while ensuring project delivery.
• SOLUTION-oriented with decision-making skills under pressure.
• Strong English skills (B2-C1 level); intermediate French (B1).