Analytical Expert (m/f/d)

at  Datalynx AG

For our client, a well-known pharmaceutical company in Basel, we are looking for an Analytical Expert (m/f/d).

BACKGROUND

We are at the forefront of innovative therapies with 14 Radio Ligand Therapy (RLT) projects in our rapidly expanding development pipeline. As part of our Global Technical R&D team, the Analytical Research & Development (ARD) department plays a crucial role in the characterization and analysis of Small Molecule Drug Substances and Drug Products, from discovery to commercial production. We are looking for a highly motivated Analytical Expert to join our team and contribute to the success of our RLT projects.

• Plan, interpret, and report on scientific experiments to ensure timely delivery of drug substances (DS) and drug products (DP)
• Write and review key analytical documents, including methods, specifications, validation reports, stability reports, and batch records for stability and release testing, while coordinating global project activities
• Manage relationships with internal and external stakeholders, providing scientific and technical guidance on outsourced activities as needed
• Proactively identify challenges in science, technology, and GMP; propose innovative solutions and communicate issues to the Analytical Project Leader or technical team
• Adhere to SOPs, GMP standards, Quality Directives, and Health and Safety guidelines
• Contribute to analytical CMC documents and support regulatory submissions
• Drive and manage analytical activities related to RLT compounds, including impurity profiling, method development, validation, stability, and release testing
• Provide scientific guidance to cross-functional and global project teams to advance our RLT portfolio
• Foster a collaborative, positive attitude with project teams, stakeholders, and partners