NPI Drug Substance Lead - Mechelen,BE
Galapagos NV
Mechelen, Belgium
7 uur geleden
source : Experteer

NPI Drug Substance Lead - Mechelen,BE 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) Drug Substance Lead - Mechelen,BEScope of the jobGalapagos 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 a DS 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 DS lead owns and manages all DS related activities within the NPI process.Your roleThe primary accountabilities in this role are : Contribute in process design and scale-up studies managed by the CMC development teams (CMA, CPP and CQA identification, product and process monitoring strategy)Ownership and management of the VMP activities of the assigned drug product(s)Determine the process validation and product stability strategy and lead validation studiesSelection and management of external service providers (CMOs) for the Drug Substance (DS) manufacturing in alignment with CMC teams and in collaboration with procurement teamLead the launch planningContinue to own the assigned DS’s during the commercial lifecycle : o Lead investigations and deal with issues, non-conformances, complaints, OOS or changes while ensuring effective corrective and / or preventive actions.

o Perform annual product reviewo Applying continuous process verificationo Ensure business continuityo Manage improvement project and Product transfer project Job requirements 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 EnvironmentExperience setting up and maintaining collaboration with external partners and vendors;
  • Experience in VMP, Process Validation, Product Stability, Technology Transfer and Risk AssessmentExpert knowledge of Drug Substance manufacturing processes, with strong chemical backgroundUnderstanding of drug development process and NDA / MAA submissionsDemonstrated capabilities in problem solving, project management, APRsAbility to effectively prepare and / or evaluate documentation.

    Some key personal attributes are : Excellent interpersonal, listening & communication skillsWell-organized, pro-active, planner, achievement orientedAbility to make decisions in a complex environmentAmbition to innovate, desire to learn and eager to propose new ways of workingWhat’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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