Group Leader Formulation & Manufacturing - Ghent

Vacancy information

Publication date:December 18 2020
Employment type: Permanent
Sector: Pharmaceutical
Function Group: R&D

Function Group: R&D

Organization

For a young and ambitious pharmaceutical CDMO, already active in six different European cities, we are looking for a Group Leader Formulation & Manufacturing on their Ghent site. To sustain the growth of the past couple years, they are looking to strengthen their manufacturing capabilities.

The company specialises in the concrete development of medicines out of the active ingredients developed by other biopharmaceutical companies. Aside from developing the drug, they also work on the regulatory dossier preparation and the manufacturing of clinical phase1 and 2 batches.

Function

In this position you will join the Formulation and Production Team. For a wide variety of international clients, this team develops API-tailored formulations and transfers the technology into GMP manufacturing for clinical trials.

The main task of the Group Leader Formulation and Manufacturing is the planning, preparation and follow up of the assigned formulation development and GMP production projects. You will translate the needs of a client to a concrete action plan and delegate it to Scientists/Operators that which working on your projects. Your key responsibilities will be:

  • Day to day management, planning and support of the Formulation Scientists and Manufacturing Operators
  • Facilitate progression of the projects within set timelines and troubleshooting of technical issues
  • Ensure budget and GMP standards are met
  • Translate the input from the Project Managers to 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 Production Operators 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
  • Write the GMP manufacturing reports
  • Support the Formulation Scientists in the execution of formulation projects
  • Assist in meeting with Contract Givers
  • You report to the Director Formulation and Production

Requirements

We are looking for someone with the following qualifications:

  • PhD, scientific orientated such as Pharmaceutical Sciences, Bio-Engineering or Chemical Engineering
  • 2+ years of industry experience in formulation
  • Hands-on experience in the development of galenic formulations
  • Knowledge of the process to produce different galenic forms in a GMP environment

In addition to the hard skills, the following personal traits are required:

  • Confident and comfortable in taking the lead
  • You have the ability to coach and motivate
  • Highly organised and a hands-on and can-do attitude
  • High levels of initiative, self motivation and energy
  • The ability to detect problems, analyse date and multitask

Offer

In return for your work, the organisation can offer the following:

  • Ability to grow your skills in a dynamic and rapidly growing company
  • Work on a wide variety of projects, for an international client portfolio
  • High level of independency
  • Competitive renumeration package with extra-legal benefits such as: meal vouchers, group- and hospitalisation insurance and a bonus system

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Lorin Raats | Senior Consultant | Biotech/Pharma division

l.raats@qtcrecruitment.com

+31(0)630238143

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