Project Manager
il y a 1 semaine
About us
As a leading contract development and manufacturing organization (CDMO) within the pharmaceutical industry, Ardena is dedicated to supporting pharmaceutical companies, from virtual biotech to major players, in bringing their valuable molecules to the clinic and market. Our commitment extends to providing a comprehensive and integrated portfolio covering drug substance and drug product development, manufacturing, logistics, and bioanalytical services.
With a rapidly growing international orientation, Ardena boasts a team of 500+ professionals operating across five strategically located sites. Our presence spans Belgium (Gent), The Netherlands (Oss and Assen), Spain (Pamplona), and Sweden (Södertälje). Embracing an open and transparent culture, we hold team spirit, an open mindset, and ownership as key values within our organization.
We are a dynamic force in drug development, offering compelling career opportunities to skilled and motivated individuals seeking to make their mark in the rapidly expanding global pharmaceutical industry. If you're looking to thrive in a challenging contract research and development environment, collaborating with experts to innovate drugs for unmet medical needs, Ardena could be the ideal workplace for you.
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 WILL YOU 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 scientific director (director of project management office) You will closely work together with our customers and all DDM departments (Formulation & production, Analytical development, Quality, facility & material logistics)YOUR PROFILE LOOKS LIKE/ RESEMBLES
You have a master or PhD degree in a scientific discipline (Pharmacy, biotechnology, bioengineering, biomedical sciences or similar) You have at least 1 to 3 years of experience in CMC Hands-on experience in drug product analytical and/or formulation development and/or GMP is a strong added value You have excellent planning and organizational skills with demonstrated ability to deliver work on-time You are customer-oriented You are flexible, a problem solver and a team player You have an analytical mindset and you are stress resistant You have good communication skills and are fluent in English (written as well as spoken) You feel comfortable in a dynamic and changing environment You like to learn and develop yourself WHAT WE OFFER
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