Primary responsibilities of this position include chemical assays (U/HPLC chromatography, moisture determination and/or in-vitro release testing in support of the manufacture, stability and release of drug product clinical supplies. Specific duties include: Development of U/HPLC methods for composite assays and determination of impurities and degradation products as well as development of dissolution methods for polymers.
- Authoring and executing analytical method development and qualification protocols
- Authoring and performing instrument validation documents and activities, respectively
- Actively participating in routine lab maintenance activities
- Authoring cGMP SOPs and analytical method procedures
- Apply technical knowledge to the company improvement projects and the evaluation of new technology/processes. Collaborate with specialist scientific and/or technology teams.
Education Minimum Requirement:
- MS in Chemistry or related discipline; or BS with a minimum of three years relevant experience
Required Experience and Skills:
- Knowledge, understanding, and experience performing LC assays
- Formal training and experience with analytical instrumentation (e.g. HPLC, Karl Fischer Titration)
- Experience with testing of small molecules
- Ability to communicate professionally in German and English
Preferred Experience and Skills:
- In depth understanding of LC including the ability to develop HPLC and UPLC separation methodologies
- Formal training and experience with cGMP expectations, electronic notebooks, electronic data repositories, instrument validation, and SOPs
- Committed to working in a collaborative manner across functional areas
- Fast learner with an attention to details
- Effective written and oral communication skills
- Effective organization to multi-task and manage multiple projects
- Possess sound experimental design, data processing, and interpretation skills
- Knowledge of analytical method development and transfer to GMP labs
ClinTec International is a UK-based, dynamic privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assist in their key product development efforts for over a decade. At ClinTec International, we pride ourselves provides high quality, flexible and professional services and solutions to our clients. ClinTec International has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
ClinTec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. ClinTec International offers a competitive salary and rewards package.