CMC Team Leader

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c8c65

CMC Team Leader
Based in Italy

Role Purpose
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.
Represent R&D; CMC in project development governing teams.
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 i

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c8c65