Pleased to meet you, we are Galapagos , a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), 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 : The make-it-happeners’.
We are looking for a New Product Introduction (NPI) Stability & Analytical Method Lead
Scope of the job
Galapagos will be introducing new, self-developed medicinal products to the market. The role of the New Product Introduction group herein is key by acting as the link between CMC development teams and the commercial supply chain.
Therefore, as Analytical Method lead you will work closely together with both these departments as well as with Quality, Regulatory, Contract Manufacturing Organisations (CMOs) and our partner Gilead.
The Stability & Analytical Method lead owns and manages all related activities within the NPI process.
The primary accountabilities in this role are :
oLead investigations and deal with issues, non-conformances, complaints, OOS or changes while ensuring effective corrective and / or preventive actions.
oManage improvement project and method transfer projects
oManage ongoing stability programmes
oContribute to annual product review
oEnsure business continuity
Who are you ?
You have minimum five years of proven experience in this field, more specifically you have :
Some key personal attributes are :
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 !