Project Manager (CMC)

About us

Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.

The Ardena Group is operating from five sites in Europe and one in US. For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a

For the Ardena Business Unit D rug P roduct D evelopment and M anufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for a

PROJECT MANAGER (CMC)

WHAT YOU WILL WORK ON

As project manager in the drug product development and manufacturing team, you are the primary point of contact for our customers. You guide our customers from (pre)clinical development of their drug product and associated analytical methods to clinical GMP manufacturing.

Based on the customer need and together with the DDM technical experts, you define the project scope and design. You manage the project on a daily basis, from negotiation with the customer on project design and budget, through high level follow up on the execution of the project plan within Ardena Gent DDM, until completion of all deliverables. You make the connection between the customer and the internal DDM organization to assure project deliverables in accordance to set timelines, budget and agreements.

YOUR KEY RESPONSIBILITIES

• Define project scope based on customer needs
• Developing project design (content, overall plan, budget, timelines) together with Ardena Gent DDM technical experts
• Draft Statement of Work and follow-up approval process.
• Planning, management, coordination, and financial control of approved projects
• Leading the core project team (including DDM galenic lead, analytical lead and QP) and clearly communicating the agreed strategy and deliverables to all stakeholders.
• Draft and follow up on the Technical Quality Agreement and the Quality Agreement.
• Review and approval of scientific protocols and reports.
• Conflict resolving; at all times facilitating decision making in order to drive the project forward.
• Communicating progress of the project to customer as first point of contact.
• Maintaining relationship with existing customers and pro-actively advise customers on next steps / projects for their current and future projects.
• You keep yourself up to date with the latest developments and insights
• You will report to the Director Project Management
• You will closely work together with our customers and all DDM departments (Formulation & production, Analytical Development, Quality, Facility & Material Logistics)

YOUR PROFILE

WHAT WE OFFER

Next to that we also offer of course :

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Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union)  will not be given a status update. Agency calls will not be appreciated.