GMP Production Group Lead - Formulation & Tech

Ardena; Gent; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Meal vouchers

Insurance (group/hospitalization)

Group bonus system

Résumé du poste

Ardena is seeking an Associate Group Leader Production for its Drug Product Development and Manufacturing (DDM) unit in Gent, Belgium. The role focuses on planning and leading GMP production projects, guiding a team of Associate Scientists, and ensuring deliverables meet GMP quality and budget constraints.

You’ll act as expert in formulation development and GMP production, representing the team in core meetings as projects enter GMP manufacturing. English fluency is essential; Dutch is a plus.

Qualifications

• 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.
• 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.
• Excellent planning and organizational skills with ability to deliver work on-time.
• Open-minded and change oriented, always looking for ways to improve.
• Stress-resistant, solution-oriented, and driven by a 'make-it-work' mindset.

Responsabilités

• Lead a team of Associate Scientists.
• Translate input from Project Managers to executable tasks on the work-floor.
• Review Technical Quality Agreement and draft internal instructions.
• Draft and train Master Batch Record Documentation and Batch Record Documentation templates and ensure their strict use.
• Coordinate the purchase and availability of starting materials prior to start of GMP Production.
• Plan and follow up GMP Production activities, areas and equipment.
• Assist Associate scientists in documenting non-conformances to guarantee quality and compliance.
• Communicate with QA for follow up and strategy for non-conformances.
• Resolve and discuss quality-related issues with QA/QP.
• Assist in GMP Production area hands-on in case of capacity constraints.
• Write GMP manufacturing reports.
• Assist in meetings with Contract Givers.
• Report to the Associate Director Production.

Connaissances

Leadership

Planning

Team coaching

Problem solving

English communication

Formation

PhD in Pharmaceutical Sciences

MSc in Pharmaceutical Sciences

Description du poste

Ardena is seeking an Associate Group Leader Production for its Drug Product Development and Manufacturing (DDM) unit in Gent, Belgium. The role focuses on planning and leading GMP production projects, guiding a team of Associate Scientists, and ensuring deliverables meet GMP quality and budget constraints.

You’ll act as expert in formulation development and GMP production, representing the team in core meetings as projects enter GMP manufacturing. English fluency is essential; Dutch is a plus.