anacura, a family-owned, growing center of excellence in healthcare with over 250 employees consists of 4 independent business units: Labo Nuytinck, active in medical analytics and AnaBioTec, OHMX.bio and Discovery Studio, active in drug development. The labs have their main activities in a state-of-art building in a green surrounding near Ghent, Belgium.

AnaBioTec provides analytical services for characterization, assay development and quality assessment of novel and established medicines, ranging from synthetic molecules and biologics, to cell & gene therapies. With more than 25 years of experience we contribute to these medicines of tomorrow by helping our customers to accelerate their drug development journey. We support startups, biotech as well as large pharma companies worldwide from pre-clinical drug development, through clinical phases I, II, III all the way to commercialised treatments. We take proud in our flexibility, diligence and science thereby operating as an extension of our clients with tailored solutions and pro-active, science driven advice. To achieve all this, AnaBioTec is set-up as a workspace with open doors where all our employees are encouraged to continuously improve & grow and are welcomed to actively contribute to the goals of AnaBioTec.

In the context of continued growth, we are looking for a

PROJECT MANAGER BIOLOGICS and CELL&GENE THERAPIES

Function

• As a project manager you are the single point of contact for our pharma/biotech customers.
• You advise the customer in the analytical part of their drug development. You translate their needs into laboratory assignments.
• You actively maintain knowledge of current regulatory requirements and serve as a subject matter expert (SME) in regulatory or customer’s audits.
• You manage phase appropriate and ICH compliant analytical method development, validation and release/stability testing (writing, set-up, review, data management).
• You actively work together with your fellow project managers, scientists and group leads to kick-off, execute and finalize the projects in accordance with customer expectations.
• You are responsible for the interpretation and scientific evaluation of the results and reporting to the clients.
• You closely follow working methods and procedures and you are able to proactively detect issues and propose optimizations.
• You will be leading or participating in improvement projects as part of our continuous improvement company culture.
• You keep your scientific knowledge up-to-date through literature and attendance at scientific seminars.

Profile

• You have a scientific education (e.g. bio-engineer, analytical chemist, biotechnology, pharmaceutical sciences, …) or equivalent by experience. Practical lab experience in an analytical environment is an advantage.
• You have at least 5 years of experience in a laboratory environment, preferentially within the pharmaceutical industry, and you understand the analytical needs in the different phases of drug development.
• You have in-depth experience in techniques and instruments used in Cell/Gene-based or biological products such as cell cultivation, flow cytometry, qPCR, ELISA and/or chromatography (LC-CE, MS).
• Knowledge of a GxP regulated environment is considered to be a plus.
• You are highly motivated to work in an environment with a lot of variety and learning opportunities. Flexibility and agility are in your DNA.
• You can plan, organize and coordinate well, taking into account timing and budget.
• Your are known as a good communicator.
• You are fluent in English and you have a working knowledge of Dutch.

Offer

• You will be part of the anacura group, a family owned, long term focused and ambitious laboratory organization.
• You will join a dynamic team and have a position with autonomy and responsibility with opportunities to take initiatives to support further growth.
• You will be offered a competitive salary with fringe benefits, a green work environment and the possibility to join our bike lease program, flexible working hours, a healthy lunch, and a pleasant fun club.
• You are stimulated in your personal growth; we build on your talents in accordance with our ambitions.

Interested?

Your application will be considered with the greatest confidentiality. For additional information please contact Cindy Bogaert: [email protected] or +32 9 257 2018.

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