CMC Project Manager

il y a 2 semaines


CorbeilEssonnes, Île-de-France Yposkesi Temps plein

About Yposkesi

Yposkesi, a leading Contract Development and Manufacturing Organization (CDMO), specializes in gene therapy viral vector manufacturing. As a one-stop shop for biotech and pharmaceutical companies, Yposkesi offers a comprehensive range of services in lentiviral vectors and AAV (Adeno-Associated Virus) cGMP manufacturing.

Job Overview

We are seeking an experienced CMC Project Manager to join our team. The successful candidate will be responsible for managing CMC projects with a focus on profitability and customer satisfaction, ensuring compliance with regulatory requirements.

Key Responsibilities

  • Lead multi-disciplinary teams in viral vector manufacturing projects, including process development, analytical development, operations, and quality assurance.
  • Act as the key interface between Business Development, Operations, and customers.
  • Support the Sales team in commercial proposal elaboration for new customers.
  • Coordinate project progress, consolidating key project milestones, budgets, project load plans, and risks.
  • Prepare reports and communicate project progress to stakeholders and management.
  • Manage indicators to anticipate potential drifts and negotiate alternative solutions to ensure compliance with commitments.

Requirements

  • Bachelor's degree in engineering or a life sciences field with 5+ years of relevant project management experience in pharmaceutical or biotechnology.
  • Minimum of 3 years of experience in the CMC area, including Analytical Development, Process Development, or Bioproduction in biologics manufacturing.
  • Good understanding of GMPs and the regulatory environment.
  • Client-oriented with effective and responsive relationships with clients.
  • Leadership and motivational skills to engage and influence key stakeholders.
  • Ability to lead successfully in a dynamic matrix environment and manage multiple priorities.
  • Solutions-oriented and capable of making crucial decisions under pressure.
  • Strong oral and written English skills (B2-C1 level); intermediate level in French (B1).

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