Senior Analytical Chemist for Development DepartmentSenior Anal
Where: western Zealand
Salary: 50K DDK+ depending on Experience
Senior Analytical Chemist for Development Department
My client is looking for a Senior Analytical Chemist with the experience and focuses on development to help them realize their growth ambitions for the development of new pharmaceutical products.
My client is one of the Nordic region's largest pharmaceutical companies, and they develop and manufacture pharmaceutical products for their Generics' portfolio and a number of well-consolidated companies in the Nordic region.
My client handles the entire development process including formulation development, analytical method development and compilation of quality documentation used in the registration of new products. The department's analytical team of chemists and technicians play an integral role in the development process, from initial method development and optimization, through to method validation and technology transfer to commercial QC team who are responsible for analysis of commercial products.
Who are you?
You have a strong academic and professional background in analytical chemistry and chromatographic methods (primarily HPLC), and have experience with developing analytical methods in these areas.
* You have a minimum of 5 years of experience as an analytical chemist with special focus on HPLC.
* Experience in the pharmaceutical industry is a strong plus.
* Experience preparing CMC documentation for registration applications to pharmaceutical regulatory authorities is highly beneficial,
* is knowledge of analytical techniques for tablet dosage forms e.g. dissolution testing.
* Experience working in a GMP environment
* used to working with quality systems.
As a senior member of the development team, you will lead analytical development activities for assigned projects and will report directly to the Chief Development Officer.
Furthermore, you will be instrumental in maintaining the good atmosphere and positive attitude in the development lab and ensuring positive collaboration with other business functions.
What are you going to work with?
* Development and optimization of analytical methods in connection with new product development
* Participation in project teams for which you will be the senior analytical representative
* Preparation of analytical validation protocols, reports and evaluation of data
* Preparation of CMC ("quality") documentation for registration applications
* Analysis of samples to support our development studies in collaboration with our technicians
* Analytical method transfer to our commercial QC laboratory
* Evaluation of analytical methods and results from external laboratories
* Set up protocols for testing, data processing and reporting of test results
* Development and maintenance of an appropriate scientific knowledge base, particularly in relation to relevant analytical techniques
* Promoting and ensuring the correct application / interpretation of Ph. Eur and GMP in the department
* Optimization and automation of processes, procedures and equipment - with an eye on LEAN and continuous improvement
By choosing a position in with my client , you will have the opportunity to help set the agenda and thus greatly influence your own daily life. We thrive in making idea to implementation, and decisions are made quickly. You will be part of a company where employees are the driving force.
Send me an email or call me at
DK Tel: +45 78 79 47 40| Int Ext: 3424
Switzerland Tel: +41 43 508 0816