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 wil