CMC Leader Early Development - Mechelen, BE
Mechelen, Belgium
4 dagen geleden

Job description

Pleased to meet you, we are Galapagos , a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland), Italy, Spain, Germany, UK and in the US (Boston).

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before.

In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters.

Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.

We are looking for a CMC Leader Early Development

Scope of the job

The core purpose of the job is to manage the CMC activities in early development projects according to the integrated project development -, CMC - and clinical plan for various compound development projects.

You will manage the drug product development and clinical bulk supplies for various early development projects.

As an expert member of the CMC group, you will provide drug product development expertise to several early development projects.

Highly qualified in pharmaceutical technology he / she will come up with formulation and production strategies needed to support early development projects.

Your role

As CMC Leader in early development, you will be responsible for the CMC development strategy and execution thereof for various compound early development projects.

You will p rovide CMC leadership to portfolio projects in close collaboration with other CMC team members and with the Late Discovery group.

You will stay abreast of current and new technologies applicable for drug product development and clinical manufacturing and latest regulations and guidelines.

You act as the CMC project spokesperson for other departments / areas. You represent the CMC team in the Early Development Project team and Clinical Development team.

You work in the CMC development team on a project basis, together with a Drug Substance Development Leader, an Analytical Development Leader, a Drug Product Development leader, a Clinical Supplies Leader and a CMC Dossier Leader.

You are the primary contact / spokesperson for interaction with competent authorities for CMC related topics.

You interact with the CMC project managers in Planning & reporting to provide CMC budget information.

You collaborate with the internal Quality and Compliance department for project related quality topics.

Who are you ?

Master of Science (MSc) or PhD in chemistry, pharmaceutical sciences or bio-engineering or equivalent by experience.

At least 5 years of relevant experience in a CMC drug product development role, at early development stage.

Excellent verbal and written English language skills required.

Team player with strong interpersonal and leadership skills.

Ability to actively listen and engage in constructive communication with the different team members.

Strong organisation skills. Excellence in planning and supervising projects.

Hands-on and pragmatic.

What’s in it for you ?

You will be part of a fast growing and amazing company. As make-it-happener’ you will get all the support you need to make your job successful.

At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills.

Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research.

Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen !

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