CMC Project Manager
il y a 2 semaines
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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