A leading global pharmaceutical company is currently looking to hire a Scientist to be based at their site in Basel, Switzerland. The company employs over 100,000 professionals and this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Handle release of drug substance (DS) and drug product (DP), review stability raw data, and conduct administrative and documentation tasks related to analytical activities.
- Provide support to the QA Project Experts on the development project analytical activities.
- Meet quality, quantity and timelines in all assigned projects.
- Review and verify raw data generated by others; approval of tests/experiments performed by others.
- Write protocols (e.g. stability, method validation and method transfer) and scientific reports, and setup and update specifications and stability studies under minimal supervision and ensuring documentation right first time.
- Perform short finalisation of protocols and reports provided by external partner.
- Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security.
- Ensure compliance to cGMP.
- Communicate deficiencies in GMP documents (e.g. unexpected results) to QA Project Expert and support their resolution, by suggesting actions and supervising agreed follow up.
- Prepare sampling orders based on information provided by QA Project Experts, manage samples with external contract Labs and ensure the right follow up.
- Manage the GLIMS entries for release results and performs the AE approval.
- Perform data integrity checks on scientific documents containing analytical data (e.g. method validation, method transfer and stability reports).
- Actively support interactions between QA Project Experts and other departments (e.g. QC testing labs, external partners, stability sites), to ensure alignment with overall drug development/QC process, to facilitate deliveries project timelines and to contribute to team goals.
Skills and Requirements:
- Master of Science with 1 year of relevant experience or Bachelor of Science.
- 3 years of relevant experience or Apprenticeship in industry; or equivalent technical. education with 6 years relevant experience in industry or equivalent.
- Good scientific and technical knowledge in analytics.
- Good knowledge of cGMP.
- Good knowledge of software and computer tools.
- Good scientific and technical writing skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, documentation, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
- Fluent in English (oral and written).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Luke Saner on +443300524502 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.