CMC Analytics Project Manager - Ghent

Vacancy information

Publication date:January 02 2020
Employment type:Permanent
Sector:Clinical Research
Function Group:R&D

Function Group: R&D / Pre Clinical Project Manager

Organization

An organisation which is expanding their services and client portfolio is currently looking for a skilled CMC Analytics Project Manager. In order to progress drug development to its final stage and thus getting it ready for market introduction, a lot of steps have to be taken. A really important step in this cycle is the development and validation of analytical methods to support the release and stability testing of the drug substance and products, all in a GMP and FDA approved environment. This is just one of the services this organisation offers to its globally located clients.

Function

In this role, you translate clients’ analytical needs for their biopharmaceutical programs (for instance recombinant proteins, peptides, oligonucleotides, vaccines, etc.) into projects with well-defined scopes and efficient work flows. You do this by closely managing a team of experienced Laboratory Analysts to ensure projects are executed and delivered according to the client’s expectations, within the foreseen timing and budget and in accordance to the internal quality management system. In addition, you will facilitate troubleshooting, evaluation of results and follow-up of deviations with the internal Team Leaders. On a daily basis, you will interact with clients providing project updates and advise them on the next steps regarding their drug development process. In parallel and ongoing you actively contribute to improve the operational process efficiency and quality.

Requirements

We are looking for a candidate who can recognise himself/herself in the below:

  • You have a Master’s degree or PhD (p.e. bio-engineering, bio-chemistry, pharmacy)
  • You are versed in analytical techniques such as chromatography, electrophoresis and/or ELISA
  • You bring several years of relevant hands-on experience in a CMC environment including quality control
  • You are familiar with regulatory requirements for GMP, method validation, release and stability testing
  • Personality-wise you are a customer oriented people manager, a team player and problem solver with strong communication skills
  • You are fluent in Dutch and English

Offer

The organisation values the importance of her employees, therefore offering the following opportunities:

  • A position with a lot of autonomy and responsibility with lots of room to take initiatives to improve services
  • You will enable to lead a dynamic and highly motivated team of Laboratory Analysts while representing the organisation externally
  • The chance to directly interact with clients and gain insights in a diversity of drug products
  • Regular and high-level trainings on analytical technologies and GMP, but also softer skills
  • A competitive salary and flexible working hours to match

Application

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

Martin van der Velden
Principal Associate

+31(0)6-83656209
+31(0)23-7548660
m.vandervelden@qtcrecruitment.com

Apply

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