Job Description

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 international 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 an

ASSOCIATE GROUP LEADER PRODUCTION

YOUR KEY ROLE

The Ardena DDM Business unit located in Belgium provide clients with a full-service solution from formulation development, analytical method development and validation, demo batch production, stability studies, clinical GMP batch production, QC testing, labelling and randomization, QP release, storage and shipping through to regulatory support for molecules in the early phase of development. In 2022 our current drug product services in oral dosage forms (granules, capsules, tablets, solutions, etc.) expanded with aseptic Fill and Finish (F&F) capabilities for the development and clinical production of small and large molecule injectable formulations.

The Formulation and Production Team plays a key role in the development of formulations and transfer of the technology into GMP, for clinical material manufacturing.

The main task of the Associate Group Leader Production is the planning, preparation and follow up of the assigned GMP production projects. The Associate Group Leader Production is responsible for the day to day management, planning and support of the Associate Scientists performing GMP production activities with the aim of facilitating progression of the activities, troubleshooting on technical and GMP compliance issues and guaranteeing that the deliverables are met within budget and time, and in accordance of the requirements of the GMP Quality system.

In addition, you act as expert with respect to formulation development and GMP production activities:

· You function as scientific and technical problem solver in the Formulation and Production department

· You function as representative of the formulation and production team in project core meetings once the project enters the GMP manufacturing stage

YOUR KEY RESPONSIBILITIES

· Lead a team of Associate Scientists

· Translate the input from the Project Managers to executable tasks on the work-floor

· Review Technical Quality Agreement and drafts the internal instructions

· Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use

· Coordinate the purchase and the availability of starting materials prior to start of GMP Production

· Plan and follow up the GMP Production activities, areas and equipment

· Assist the Associate scientists in documenting non-conformances to guarantee the quality and compliancy

· Communicate with QA for follow up and strategy to be followed for non-conformances

· Responsible for resolving and discussing quality related issues with QA/QP

· Assist in the GMP Production area hands-on in case of capacity constraints

· Write the GMP manufacturing reports

· Assist in meetings with Contract Givers

· You report to the Associate Director Production

YOUR PROFILE

· You have a PhD with scientific orientation (Pharmaceutical Sciences, Bioscience-Engineering, Science or Chemical Engineering,…) or MSc in Pharmaceutical Sciences with around 4-7 years of GMP experience

· You have a strong understanding of the process and preparation of different galenic forms (oral and topical dosage forms)

· Experience in a GMP environment is a big plus

· You have excellent planning and organizational skills with ability to deliver work on-time

· You show flexibility and you are open-minded and change oriented (always looking for ways to improve)

· You are stress-resistant, solution-oriented, and driven by a 'make-it-work' mindset.

· You are able to coach and motivate the operators/scientists executing the work

· You have strong reporting skills (oral, written, presentations)

· You are a team player

· Excellent communication skills in English; Dutch language skills are a plus.

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

· An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance and a group bonus system