Associate Group Leader Production

Ardena Careers; Gent; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Group/hospitalization insurance

Group bonus system

Résumé du poste

Ardena Careers in Gent, Belgium, is seeking an Associate Group Leader Production to oversee GMP production projects and lead a team of Associate Scientists. The successful candidate will require a PhD in pharmaceutical sciences or an MSc with 4-7 years of GMP experience. This key role involves planning, technical problem-solving, and ensuring compliance in production activities. Ardena offers a dynamic working environment with growth opportunities and an attractive remuneration package including meal vouchers and insurance.

Qualifications

• PhD in pharmaceutical sciences, bioscience-engineering, or chemical engineering.
• Strong understanding of preparation of different galenic forms.
• Experience in a GMP environment is a plus.

Responsabilités

• Lead a team of Associate Scientists.
• Review Technical Quality Agreements and draft internal instructions.
• Plan and follow up GMP Production activities.

Connaissances

Excellent planning and organisational skills

Strong reporting skills

Excellent communication skills in English

Ability to coach and motivate

Formation

PhD in pharmaceutical sciences or MSc with 4-7 years GMP experience

Description du poste

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.

Ardena is a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) that 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.

Ardena is science‑driven and people‑focused. Collaboration, innovation, and curiosity are encouraged. We value communication, accountability, reliability, and excellence.

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

Business Unit: Drug Product Development and Manufacturing (DDM)

Associate Group Leader Production

Your Key Role

The Ardena DDM Business Unit located in Belgium provides clients with a full‑service solution from formulation development to regulatory support for molecules in early phase development. In 2022 our services expanded with aseptic Fill and Finish capabilities for small and large molecule injectable formulations.

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

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

You act as an expert in formulation development and GMP production activities, functioning as a scientific and technical problem solver and representing the team in project core meetings once the project enters 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 Agreements and draft internal instructions
• Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use
• Coordinate purchase and availability of starting materials prior to the start of GMP Production
• Plan and follow up GMP Production activities, areas and equipment
• Assist the Associate scientists in documenting non‑conformances to guarantee quality and compliance
• Communicate with QA for follow‑up and strategy to be followed for non‑conformances
• Resolve and discuss 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
• Report to the Associate Director Production

Your Profile

• PhD in pharmaceutical sciences, bioscience‑engineering, science or chemical engineering, or MSc in pharmaceutical sciences with 4‑7 years GMP experience
• Strong understanding of the process and preparation of different galenic forms (oral and topical dosage forms)
• GMP environment experience is a big plus
• Excellent planning and organisational skills with ability to deliver work on‑time
• Flexibility, open‑mindedness, and change orientation (always looking for ways to improve)
• Stress‑resistant, solution‑oriented, and a ‘make‑it‑work’ mindset
• Ability to coach and motivate operators/scientists executing the work
• Strong reporting skills (oral, written, presentations)
• Team player
• Excellent communication skills in English; Dutch language skills are a plus

We Offer

• A true learning environment where you can 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
• An open, straightforward, caring culture
• A love of creative thinking and pro‑activeness
• Alignment with Ardena values
• An attractive remuneration package with extra‑legal benefits such as meal vouchers, group/hospitalization insurance, and a group bonus system