CMC Project Manager
il y a 1 mois
A propos
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’s is located on the Genopole Campus in Corbeil-Essonnes (South of Paris), France and currently employ of ~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?
Votre mission
About the role :
Reporting to the Director of CMC project management, the CMC Project Manager ensure the management of 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 Sales team in commercial proposal elaboration for new customers. 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 indicators to anticipate potential drifts and negotiate, with contributing departments, alternative solutions to ensure compliance with commitments.Profil recherché
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); intermediate level in French (B1).-
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