Analytical Scientist
SIRE
Zuid-Holland, The Netherlands
21 dagen geleden

The company

Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands. The client is a large globally operating generic company.

Their mission is to accelerate access to affordable medicines and finding solutions for unmet needs because we believe Good Health Can’t Wait.

Role description

Working as an experienced Analytical Scientist to assist in product development in a dynamic and rapid paced working environment.

You will be in 1 or more projects in parallel with the team depending on complexity. Your efforts will be fully integrated within the product development and you will take part of formulation activities (both practically and theoretical) but with your expertise in analytical development.

In this dynamic role, your insights will be fully utilized to allow rapid delivery of a quality product.

Responsibilities

As an analytical scientist for the early stage development group you are responsible for analytical method development within the team and you are able to reach POC at bench scale for complex generic injectables with the team.

You will be required to leverage your expertise, in collaboration with others, to make the best choices with respect to your development activities.

Next to this you will be responsible for the following :

  • Apply analytical QbD and DoE.
  • Ensuring that methods are validatable.
  • Ensuring that your work is done based on the ICH-, FDA, and EMEA guidelines.
  • Once robust analytical methods have been established, you will also support the formulation team to increase product and process understanding while performing the required analyses and characterization.
  • Requirements

  • Master or a PhD in pharmaceutical science or (analytical) chemistry
  • At least 3 year of experience with a PhD degree or 6 year of experience with a Master degree
  • You understand FDA, EMEA and ICH and GLP and or GMP requirements for analytical method development.
  • Fluent in English (spoken and written)
  • Experience with Analytical development
  • Knowledge of HPLC / UPLC, LC-MS, GC-MS, Empower, chromatography, Karl Fischer, Statistical testing, QbD / DOE
  • Knowledge of Injectables is a big plus
  • Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.

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