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 involved.

Conformance to plan (quality, timeline and budget)



of external manufacturing partners.

Opportunities to reduce cost of goods and improve security of clinical supply and future commercial supply chain with robust processes.

Drive integration of new technology and digital solutions.

Support global intellectual property strategies on core innovations.

Author and support Regulatory filings for clinical trials and marketing approval.

Experience & Qualifications

Master Degree in Scientific Disciplines (Pharmacy, Chemistry, Pharmaceutical Chemistry & Technology, Biotechnology or Chemical Engineering).

10+ years’ experience in multiple pharmaceutical product development and manufacturing functions.

Proven expertise in delivering innovative new medicinal products from early development to product launch for global markets.

Expert knowledge of current global regulatory expectations and product development process.

Team Leadership

Behaviours

Foster an environment of trust and transparency, ensuring all stakeholders are well-informed and encouraged to communicate openly.

Promote powerful networks, cross-boundary collaboration, and a continuous learning culture.

Inspire proactive innovation, initiative, and data driven risk based decision making processes.

Build a performance culture dedicated to exceeding expectations and elevating the importance of patient focused product development and launch.

Extra Information

Remote options can be available, location in Italy (Tuscany) preferred.

Travel up to 20%, to ensure presence in key internal sites (Pisa, Florence, Berlin) and CDMO/CMO/CRO as needed.

Fluency in English required; Italian also preferred The selected candidate will be employed under Category 'A' in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.

Menarini

Stemline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

📌 CMC Team Leader (Toscana)
🏢 MENARINI Group
📍 Toscana