CMC Team Leader
Pubblicato il 03-09-2026 - MENARINI Group in Toscana
Lead cross-functional R&D; CMC matrix teams focused on oncology product development, regulatory submissions, transition to commercialisation and LCM.
Key Responsibilities
- Provide strategic and operational leadership for the R&D; CMC Team to design, develop and register innovative oncology products, with a primary focus on small molecules.
- Execute strategies and tactical priorities as defined by senior leaders, ensuring on time and in budget delivery.
- Serve as the primary interface between R&D; CMC and Technical Operations to deliver all technical, manufacturing, and regulatory deliverables.
Lead Cross-Functional Teams to Deliver:
- CMC strategies, business cases and budgets.
- Evaluation and contracting of new research and manufacturing partners.
- Integrated regulatory strategies to expedite project progression.
- Technical risk assessments, risk scoring and mitigation activities to proactively address complex R&D; CMC scientific, technical, and clinical supply chain issues.
- Hit to Lead optimisation and molecule selection.
- Drug substance objectives (design,
develop and refine synthetic chemistry route; produce materials for R&D; trials, clinical trials and regulatory registration, develop integrated technology transfer plan).
- Drug product objectives (design, develop and refine formulation and processes; produce materials for R&D; trials, clinical trials and regulatory registration, develop integrated technology transfer plan).
- Analytical objectives (design, develop and refine methods and specification; test materials for R&D; trials, clinical trials and regulatory registration, develop integrated technology transfer plan).
- Investigational medicinal objectives (design, develop and refine clinical supply chain; supply materials for R&D; trials, clinical trials and regulatory registration).
- Conformance to Quality requirements (in synergism with QA rep) in any phase and countries involved.
- Conformance to plan (quality, timeline and budget) of external manu