In this role, you will be responsible for designing and analyzing experiments related to drug substances and products, ensuring timely delivery of data. You will review and prepare analytical documentation, coordinate with internal and external stakeholders, and troubleshoot scientific and GMP-related issues. Your work will adhere to established SOPs and quality standards, supporting development and manufacturing processes.
Start Date: 01/09/2025
Duration: 16 Months
Place of Work: Basel
Key Responsibilities
* Design, execute, interpret, and document scientific experiments to support the supply of drug substances and drug products
* Conduct raw data reviews for externalized analytical activities
* Prepare, review, and maintain analytical documentation, including methods, specifications, validation reports, stability reports, and batch records
* Manage communication and collaboration with internal teams and external CROs, providing scientific guidance as needed
* Identify potential scientific, technological, or GMP challenges, propose innovative solutions, and communicate issues to project teams
* Ensure compliance with SOPs, GMP, Quality directives, and safety standards
Job ID 41181086
Candidate Profile
* PhD or Master’s degree in analytical chemistry or a related field
* Minimum of 5 years of industry experience with GMP activities related to development or marketed products
* Strong expertise in raw data management and documentation, including stability reports and validation procedures
* Broad scientific knowledge in chemistry, pharmaceutical, or analytical sciences, with the ability to thrive in a fast-paced environment
* Proficient in laboratory techniques and technical tools such as HPLC, LC-MS, and statistical analysis software
* Familiar with laboratory management and quality systems software
* Excellent scientific and technical writing skills
* Fluent in English, both spoken and written
* Experience with inhaled dosage forms is highly desirable
#J-18808-Ljbffr