Scientist IMP In-Process Controls

Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Background:

The department is responsible for the process analytics during the manufacturing of chemically synthesized Active Pharmaceutical Ingredients (APIs). This includes reaction controls and the analysis of isolated intermediates, strictly adhering to cGMP, safety, and regulatory requirements. We are seeking motivated individuals to actively contribute to a variety of engaging tasks within our Manufacturing Analytics Team.

Tasks & Responsibilities:

• Provide essential guidance to laboratory colleagues on the planning, execution, and conclusion of analytical tests for in-process and intermediate analytics
• Ensure strict compliance with cGMP (current Good Manufacturing Practice), safety standards, and regulatory requirements across all analytical activities
• Thoroughly review analytical methods and specifications originating from the analytical development department
• Implement and establish new analytical methods from development into the production-accompanying control process
• Generate and meticulously check analytical documentation, maintaining a high focus on quality, data integrity, and meeting defined deadlines
• Take initiative and ownership in the timely processing and documentation of deviations and non-conformances
• Actively participate in crucial quality assessments and investigations to uphold product integrity
• Contribute to process optimization by assisting in the development and implementation of lean, efficient working processes

Must Haves:

• You hold a Master's degree or university degree in Natural Sciences, or have completed a Chemical Laboratory Technician apprenticeship with extensive, relevant professional experience (No PhD) 
• Min. 3 year proven, hands-on experience with a variety of analytical techniques relevant to chemical manufacturing processes.
• Confident with physical chemical analytical techniques (Chromatography) 
• Strong commitment to quality and a high level of awareness regarding data integrity and documentation accuracy.
• Sound knowledge of GMP principles (Good Manufacturing Practice) and regulatory requirements in the pharmaceutical industry 
• To perform effectively in this role, advanced German (C1) & English language skills are required 
• Able to demonstrate excellent organizational skills and the ability to effectively manage and prioritize multiple tasks in a dynamic environment
• Proactive team player with a strong sense of responsibility and a high willingness to learn and adapt
• You are capable of thriving in an agile matrix organization and successfully contributing to shared, cross-functional objectives

What you will be offered:

• An opportunity to work in one of the world's most important pharmaceutical companies
• Modern campus with plenty of green spaces and meeting areas
• Central location in Basel
• Varied job profile
• Further training opportunities through temptraining
• Working in a dynamic and motivated team

If you are interested please send your application documents addressed to Ms Marianne Buser.

Basel-Stadt Pharma Chemie In-Process Controls (IPC) cGMP Analytische Methoden Datenintegrität Prozessoptimierung