Analytical Project Strategy Leader

4 settimane fa

Roma, Lazio, Italia Advanced Accelerator Applications (Italy) - S... A tempo pieno
Job Summary:

As an Analytical Project Strategy Leader at Advanced Accelerator Applications, you will be responsible for defining, leading, and managing the analytical project strategy for Drug Substance(s) and radiopharmaceutical parenteral Drug Product(s). This includes developing an overall science and quality-driven analytical project strategy, ensuring project-specific high-quality analytical submission documents, and supporting the analytical team members in achieving the overall Technical Research and Development strategies and goals.

Key Responsibilities:

• Define and develop an overall science and quality-driven analytical project strategy, including contingency plans and risk evaluations for RLT DS and RLT DP.
• Ensure transparent communication to the appropriate management level and/or to any other relevant project team member(s).
• Be a core member of the TRD sub-team representing RLT Analytical Science, co-owning the technical development together with the DSPL and RLT DPPL, and actively contributing to the definition of the overall technical development plan.
• Lead and coordinate analytical activities, such as method development and validation, DS/DP stability, DS/DP release, reference nomination, and transfer activities, across all analytical sites and partnering functions.
• Accountable for driving the testing strategy of RLT DS/DP and specifications setting.
• Be the RLT Analytical Science project representative in peer review and governance boards, as well as in internal and external audits.
• Support the assessment, forecast, and monitoring of monthly resource needs and reflect in TRD planning tools, ensuring budget adherence.
• Ensure the creation of an overall high-quality control strategy with partnering functions (CHAD, PHAD) and the documentation of the analytical/testing control strategy.

Requirements:

• PhD in chemistry, pharmaceutical technology, or equivalent scientific degree with minimum 5 years of successful industry experience in the analytical chemistry and/or radiochemistry development and/or quality control with project management experience.
• Fluent knowledge of English (oral and written).
• Desirable knowledge of site language.
• Proficiency in quality principles driving drug development, such as GMP, and a clear understanding of current and anticipated regulatory and quality expectations, preferably in the radiopharmaceutical industry.
• Strong experience in writing CMC documents for regulatory submissions and responding to health authority questions.
• Strong experience with outsourcing and coordinating work done by CRO/CMOs, including technical overview of agreement setup.
• Awareness for safe handling of chemicals, potentially dangerous materials, and equipment.

About Us:

At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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