Requirements: English
Company: Experteer Italy
Region: Ivrea , Piedmont
SummaryLocation: Ivrea, ItalyRole Purpose: Define, lead, and manage the analytical project strategy, including the overall analytical control strategy for Drug Substance(s) and radiopharmaceutical parenteral Drug Product(s), aligned with the CMC project development plan. Ensure high-quality analytical submission documents. Support and mentor analytical team members, contributing to the overall Technical Research and Development strategies and goals.About the RoleRole responsibilities:Define and develop a science and quality-driven analytical project strategy, including contingency plans and risk evaluations for RLT DS and RLT DP.Ensure transparent communication with management and relevant project team members.Be a core member of the TRD sub-team representing RLT Analytical Science; co-own the technical development with DSPL and RLT DPPL, and contribute to the technical development plan.Lead and coordinate analytical activities (method development and validation, stability, release, reference nomination and transfer) across all analytical sites and functions.Drive testing strategy and specifications setting for RLT DS/DP. Represent RLT Analytical Science in peer reviews, governance boards, audits.Support resource planning, budget adherence, and reflect needs in planning tools.Create and document high-quality control strategies with partnering functions.Handover analytical documents to partners, including responding to health authority questions and supporting interactions across sites and functions. Assist in outsourcing projects and QA agreements.Essential Requirements:PhD in chemistry, pharmaceutical technology, or equivalent, with at least 5 years of industry experience in analytical chemistry, radiochemistry, or quality control, including project management.Fluent in English (oral and written); knowledge of site language is desirable.Proficiency in GMP and current/regulatory quality principles, preferably in radiopharmaceuticals.Experience in writing CMC documents for regulatory submissions and responding to health authority inquiries.Experience with outsourcing, CRO/CMO coordination, and technical oversight.Awareness of safe handling of chemicals and hazardous materials.Why Advanced Accelerator Applications?Our mission is to transform lives through radioligand therapy in nuclear medicine to fight cancer. We foster innovation at the intersection of science and digital technology, promote diversity and inclusion, and believe in an unbossed culture rooted in integrity, curiosity, and flexibility. Join us in tackling the world''s toughest medical challenges and making a difference.#J-18808-Ljbffr