Hands off- position for an experienced Scientist (MSc / Phd) with an analytical background within farma / biotech. A challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
- The analytical development quality team focuses on the design, execution and evaluation of stability profiles and qualification of Reference Materials for novel vaccines. The group supports the clinical development stages of the vaccines platforms and generates data that is used in preparation for future commercialization.The Scientist will be a key player in the management of the various reference material studies of the novel vaccines during the clinical development. Since the scientist is providing support to various CMC projects that are carried out in teams comprising members from different departments, teamwork and flexibility are two very important personal characteristics.
- Preparation of qualification protocols, qualification reports, Certificate of analysis, trending and monitoring fo Reference Materials;
- Review and approval of various scientific protocol, reports, documentation for IND/CTA filing;
- Providing support during scientific investigations;
- Acting as a support to Head of QC during audits, inspections, assessment of quality of suppliers and data decisions on products tested within QC;
- Leading quality investigations (Deviations, OOS, CAPAs);
- Since the scientist is providing support to various CMC projects that are carried out in teams comprising members from different departments, teamwork and flexibility are two very important characteristics that are required attributes;
- We offer a challenging position which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.
- MSc or Ph.D. Degree in Biochemistry, Pharmacy, or equivalent life sciences degree;
- A minimum of 2-3 years pharmaceutical industry experience working under GMP standards;
- Experience with reference Material qualification/bridging/management;
- Experience with analytical methods qualification and validation;
- Knowledge of statistical analyses and data trending;
- Knowledge of GMP quality systems, quality management;
- You are independent, flexible, motivated and enjoy working in a team;
- Excellent organizational and communication skills, and a strong scientific mindset are key for this position;
- English is a must, Dutch is considered a plus;
- Valid Dutch work permit is a must;
- Contract: 1 year via Oxford, realistic long- term perspective;
- Salary: €3400- €4400 gross monthly based on education and experience;
- Holiday: 25+12;
- Working hours: full-time, 32 hours discussable;
- Region: Leiden.