Global Senior Pharma Process Manager - MS&T

Overview

The role is a senior-level position within the Global Manufacturing Science & Technology (MS&T) department at the Menarini Group, based in Florence. Reporting directly to the Global MS&T Lead , the manager acts as a strategic technical bridge between R&D, Manufacturing, Quality, Regulatory Affairs, Supply Chain, and CMOs. The primary mission is to lead industrialization, process optimization, and technology transfer programs to ensure robust, scalable, and compliant manufacturing processes across the product lifecycle.

Main Activities & Responsibilities

Industrial & Process Strategy

• Assess Scalability: Support industrialization and technology transfer activities by evaluating process scalability, manufacturability, and operational robustness.

• Risk & Parameter Identification: Contribute to identifying and evaluating Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and process-related risks that impact product quality, reliability, and supply continuity.

• Strategic Partnering: Partner with the MS&T Lead and cross-functional stakeholders to evaluate manufacturing strategies, balancing quality, compliance, timing, cost, and operational efficiency.

• Issue Escalation: Escalate technical and operational issues when appropriate, providing data-driven analyses and recommendations.

2. Program & Stakeholder Management

• Cross-Functional Coordination: Coordinate activities involving Production, QA, QC, Regulatory Affairs, Engineering, Supply Chain, and external CMOs during industrialization and technology transfer projects.

• Project Planning: Support project planning and execution, ensuring alignment on timelines, priorities, risks, and resource allocation across multiple stakeholders and manufacturing sites.

• Technical Reference Point: Act as the primary technical contact for assigned projects to facilitate communication, resolve issues, and streamline decision-making processes.

• Leadership Reporting: Ensure effective reporting of project status, risks, and technical challenges to MS&T leadership.

3. Process Excellence & Troubleshooting

• Deviation Investigations: Support investigation activities related to process deviations, variability, and performance optimization.

• Continuous Improvement: Drive continuous improvement initiatives to enhance process robustness and efficiency.

Job Requirements

Education & Experience

• Degree: Master’s Degree in CTF (Chimica e Tecnologia Farmaceutiche), Chemistry, Pharmacy, or Chemical/Process Engineering.

• Experience: 10–15 years of experience in pharmaceutical manufacturing, MS&T, industrialization, process engineering, or technology transfer.

• Pharmaceutical Forms: Strong, proven exposure to solid dosage manufacturing environments, as well as experience across other pharmaceutical forms such as steriles.

• Scale-up & Validation: Direct involvement in industrial scale-up, process validation, and process troubleshooting activities.

• International Network: Experience within multinational manufacturing networks and/or CMO management is considered a strong plus.

Technical Skills

• Deep understanding of pharmaceutical manufacturing processes and industrial scale-up principles.

• Solid knowledge of GMP environments, process validation regulations, and technology transfer guidelines.

• Proven ability to analyze and interpret process data, process variability, and critical process parameters (CPPs).

• Advanced knowledge of problem-solving and investigation methods, such as Root Cause Analysis, Fishbone diagrams, the 5 Whys, and FMEA, to support process deviation and troubleshooting activities.

Soft Skills & Leadership

• Project Management: Strong project and stakeholder management capabilities within cross-functional and international environments.

• Problem Solving: Excellent problem-solving skills utilizing a structured, risk-based approach.

• Communication: Strong communication and influencing capabilities across both technical and non-technical stakeholders.

• Adaptability: High adaptability and the ability to operate effectively in complex, dynamic industrial environments.

• Decision Making: Ability to balance technical, quality, regulatory, and operational priorities.

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, with an estimated annual base salary between Euro 60.000,00 and Euro 65.000,00, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026.