Product expert Jobs in Pratteln

Looking to uncover insights that could revolutionize the future of medicine and drive breakthroughs in patient care?

Proclinical is seeking an Analytical Research Expert to support Analytical Research and Development (ARD) within the pharmaceutical development space. This role focuses on the characterization and analysis of small molecule drug substances and drug products. You will play a key role in driving method development, managing analytical activities, and supporting regulatory submissions.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities :

• Plan, analyse, and report results of scientific experiments for timely supply of drug substances and drug products.
• Write and review analytical documents, including methods, specifications, validation reports, stability reports, and batch records.
• Drive method development for peptide drug substances and radioligand therapy (RLT) drug products.
• Manage interactions with internal and external stakeholders, including outsourced activities to CROs, providing scientific and technical guidance.
• Identify scientific, technological, and GMP challenges, propose solutions, and communicate key issues to project leaders or teams.
• Ensure compliance with SOPs, GMP, quality directives, health and safety standards, and internal guidelines.
• Provide input to analytical CMC documents and support regulatory submissions.
• Lead analytical activities such as impurity profiling, method development, validation, stability, and release testing for RLT compounds.
• Offer scientific guidance to cross-functional and global project teams, driving the RLT portfolio.
• Collaborate effectively with project teams, stakeholders, and partners.

Key Skills and Requirements :