Job Description

About us

At Ardena, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world.

As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards.

With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support.

But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged.

We offer an i nternational environment where you can learn, take initiative, and grow your career across teams, functions, and locations Our way of working is guided by our CARE values Communicative, Accountable, Reliable, and Excellent These values shape how we collaborate, solve challenges, and support each other every day.

At Ardena, you’re not just building your career — you’re helping build the future of medicine.

For the Ardena Business Unit Drug Product Development and Manufacturing (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 and getting the drug product to clinical trials.

Based on the customer need and together with the 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 quotes 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 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

· You have a master or PhD degree in Pharmacy (or other scientific discipline with experience in the pharmaceutical industry)

· 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 ability to deliver work on-time

· You see things from a commercial perspective and you are customer oriented

· You are flexible, stress resistant and a problem solver

· You have good communication skills and are fluent in English (written as well as spoken)

· You feel comfortable in a dynamic and changing environment

WHAT WE OFFER

· A true learning environment where you will have the ability to grow your skills

· A rapidly international developing and growing company with an interesting services, product and customer portfolio

· A dynamic working environment with nice colleagues

· Open straightforward but also caring culture

· We love creative thinking and pro-activeness

· We are true to our values

Next to that we also offer of course:

· An attractive remuneration package including benefits

· Flexible working hours + option to work partially from home once trained

· 32 days holiday a year