CMC Team Leader

MENARINI Group; Toscana; Ibrido; EUR 150.000 - 190.000; Tempo pieno

Descrizione del lavoro

Menarini Stemline is seeking a senior leader to head cross-functional R&D CMC teams focused on oncology product development. You will design, develop and register innovative oncology medicines, guiding regulatory submissions and transition to commercialization while enabling lifecycle management.

The role demands 10+ years in pharma development, strategic and operational leadership, and strong collaboration with QA, Regulatory, and Clinical Operations across global sites.

Competenze

• Master's degree in a scientific discipline relevant to pharma.
• 10+ years in pharmaceutical product development and manufacturing.
• Proven track record delivering medicines from development to launch.
• Expert knowledge of global regulatory expectations.
• Fluency in English; Italian preferred.
• Willingness to travel up to 20%.
• Remote options may be available; location in Italy preferred.

Mansioni

• Provide strategic and operational leadership for the R&D CMC team to develop oncology products.
• Deliver on-time, on-budget strategies and priorities defined by senior leaders.
• Interface between R&D CMC and Technical Operations for deliverables.
• Lead CMC strategies, budgets, and partner evaluations.
• Oversee regulatory strategies to expedite progression.
• Assess and mitigate technical risk across R&D CMC and supply chain.
• Support tech transfer, drug substance and drug product objectives.,
• Contribute to IP strategy and regulatory filings for trials and approvals.

Conoscenze

Strategic leadership

Cross-functional leadership

Regulatory strategy

Project management

Communication

Team collaboration

Data-driven decisions

Risk management

Pharmaceutical development

Technology transfer

Formazione

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

Descrizione del lavoro

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 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.
• 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.
• 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.