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Scientist Analytical Development & Validation Leiden Netherlands,
Posted on : 27 April 2017
Your role as a Scientist Analytical Development & Validation
- 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 organisation as well as for other Business Units within the company Sinensis Life Sciences group, such as the Manufacturing unit, MicroSafe and company 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 optimized 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.
A world of possibilities
At our company we highly value our strong team spirit and encourage collaboration between colleagues.
Our company 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 our company Laboratories offers you the flexibility and personal touch of working in a medium sized and dynamic company, whilst also allowing you to benefit from having company 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 company
- A broad customer portfolio ensuring a lot of diversity in your work.
2333 CM Leiden The Netherlands
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