NPI Stability & Analytical Method Lead- Mechelen,BE
Galapagos
Mechelen, Belgium
5 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 & 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.

Your role

The primary accountabilities in this role are :

  • Contribute in the development and validation of analytical methods and stability studies managed by the CMC development teams
  • Ownership and management of the stability strategy and stability studies of the assigned drug substance(s) and drug product(s) with consideration to meet global market requirements and regulatory guidelines
  • Selection and management of external service providers for the maintaining / improving the analytical methods and stability programmes in alignment with CMC teams and in collaboration with procurement team
  • Maintain knowledge of global regulations that impact stability
  • Continue to own the assigned products during the commercial lifecycle with regard to stability and analytic methods
  • 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 :

  • Experience in Biotech, Biopharmaceutical or Pharmaceutical, specifically in New Product Introduction Environment
  • Strong knowledge of stability guidelines (ICH) and analytical method development and validation
  • Experience in Life Cycle Management, Technology Transfer and Risk Assessment
  • Experience setting up and maintaining collaboration with external partners and vendors;
  • Understanding of drug development process and NDA / MAA submission
  • Demonstrated capabilities in problem solving, project management, APRs
  • Ability to effectively prepare and / or evaluate documentation.
  • Some key personal attributes are :

  • Excellent interpersonal, listening & communication skills
  • Well-organized, pro-active, planner, achievement oriented
  • Ability to make decisions in a complex environment
  • Ambition to innovate, desire to learn and eager to propose new ways of working
  • 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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