Analytical Scientist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.
- 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.
- 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
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.
The Company
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
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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