Scientist Analytical Development & Validation
- Leiden, Netherlands
For Eurofins PROXY Laboratories B.V. in Leiden we are looking for a Scientist Analytical Development & Validation.
PROXY Laboratories is a GMP Quality Control laboratory, where analytical chemical testing of raw materials, drug substances and drug products is performed. A large part of this work comprises routine compendial testing. However for new products, formulations or monographs clients require development or validation of analytical methods. The Project Management group is responsible for this type of work.
In this position within the Project Management department, you will supervise a diverse array of projects concerning the development and validation of analytical methods for pharmaceutical products and dosage forms. These projects typically involve method transfer, verification, feasibility and validation. The focal point in this position lies at complex, non-standardized analytical method development and optimization applied to protein formulations and their impurities, related substances and excipients; and troubleshooting of relevant analytical methods. You are a sparring partner for our scientists and technicians, both within the PROXY organisation as well as for other Business Units within the Eurofins Bio Pharma Product Testing group, such as the Manufacturing unit, MicroSafe, Bactimm and Spinnovation Analytical.
As a scientist you
- lead projects on development, optimization and validation of analytical methodologies using a large variety of techniques, including but not limited to LC, LC-MS and CE;
- generate and review documentation such as protocols and result reports;
- provide internal consultative support and troubleshooting for analytical methods;
- select and introduce new analytical technologies for our laboratory;
- act as a consultant for customers on analytical issues
You will be responsible for the analytical methods of new and adjusted pharmaceutical formulations. These (re)developed and optimised methods will be transferred to the Quality Control laboratory of our organization. Accurate documentation compliant to GMP guidelines will be an integral part of your work.
For this position we will select experienced candidates with the following background:
- PhD or MSc degree in analytical chemistry, biochemistry or organic chemistry.
- At least five years of relevant experience with the following chromatography techniques: GC, HPLC and LC/MS with several detection techniques.
- Working experience in development and validation of analytical methods, preferably in a biotech/biopharma company.
- Independent, thorough and able to perform under pressure
- Strong team player
- Hands-on mentality
- Result- and customer-oriented
- Excellent communication skills
- Good command of the English language, and at least a basic understanding of Dutch
In addition, the following items are recommendations for this position:
- Working experience as a project manager or supervisor
- Experience with pharmacopoeial methodologies
- Working knowledge of GxP and/or EMEA/FDA guidelines
- Working experience in a (bio)pharma manufacturing environment
PROXY and Eurofins: A world of possibilities
This position is based at PROXY Laboratories on the Biosciencepark in Leiden. At PROXY we highly value our strong team spirit and encourage collaboration between colleagues.
PROXY offers a wide range of personal and professional possibilities:
- • A responsible and challenging position within the team;
- • Plenty of room for your own ideas and input;
- • Specialist training and a range of opportunities for personal and professional development;
- • Flexible working hours;
- • Good salary and benefits.
Working at PROXY offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for the motivated employees:
- • Plenty of opportunities for growth;
- • Varied work where you are in regular contact with other companies and scientists within the Eurofins group ;
- • A broad customer portfolio ensuring a lot of diversity in your work.
Would you like to know more?
For questions regarding the position, please contact our Human Resources Department at 071 524 40 80.
Acquisition for this vacancy is not appreciated.