Global Senior Pharma Process Manager– MS&T

Overview

Sebbene l'esperienza professionale e le qualifiche siano fondamentali per questo ruolo, si assicuri di verificare di possedere le soft skill preferenziali, se richieste, prima di candidarsi.

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

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• 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

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• 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

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• 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

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• 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

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• 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 xbvzest 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

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• 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 Nationa