Technical Leader Respiratory, Orals & Small Molecules (Process Validation & Life Cycle Management)

This is what you will do

You will act as the global technical reference for Respiratory, Orals & Small Molecules, ensuring technical robustness throughout the product lifecycle and delivering innovative, compliant solutions supporting the business and Quality organization.

You will contribute to the definition and execution of the industrialization strategy for new products within the R&D Product Teams, acting as a member of the Extended Technical Team. You will structure, plan, and coordinate industrial process validation activities to ensure robust and compliant manufacturing processes. In addition, you will provide technical leadership for lifecycle management projects concerning established products, overseeing the technical assessment and implementation of modifications to critical components, including APIs, excipients, devices, and packaging materials.

You’ll be responsible for:

• Design and implementation of structured validation approach in line with agencies and regulatory expectations to support properly the business continuity;
• Design and implementation of structured validation approach in line with strategic and business objectives, evaluating and adequately balancing economic aspects, commercial impacts and technical risks;
• Guarantee strategic design and approach compatible with defined timelines and cost, product availability and geo-expansion;
• Guarantee strategic process harmonization at global level, to prevent non-compliances and regulatory agencies observation or extra-costs;
• Participate or lead lifecycle management projects on consolidated products for modifications to critical components (APIs, excipients, devices, packaging materials);
• Participate or lead constructively Industrial Management projects from the consolidated portfolio for change of production site or changes on critical components (contact packaging materials, excipients or APIs) for modifications to the material in use or inclusion of a new supplier;
• Participate or lead constructively Extended Teams and work packages development meetings when required (e.g., Extended Technical Teams, Technical Maintenance, Operative Teams,…);
• Be the key reference person for Global TechOP&S functions (incl. plant Site Process SME - Parma, Blois, Santana, Virtual plant) supporting with technical expertise for maintenance activities for in-market products, regarding maintenance needs collection, planning and execution, challenges identification, supporting geo-expansion and module 3 maintenance, reporting to dedicated governance bodies;
• Support the development and evolution of Chiesi products toward sustainability-driven initiatives, through the Ecofriendly challenge;
• Support Global TechOP&S PM’s with the preparation of key deliverables for governing bodies (Global Tech Op&S Leadership Team) updates on LCM activities (e.g., business case);
• To support qualitative investigations (deviations, OOS, complaints), providing technical/scientific input through data collection and data analysis;
• To support Chiesi functions (Global and Local) in preparation to audits (inspection readiness streams);
• Collaborate with Virtual Plant Managers and Procurement defining commercial and technical agreements for technical contents and participate to due diligence activities;
• To provide scientific evaluation and effective methodological support in problem solving, contributing in a significative way to identify root causes;
• Accountability for Technology transfer activities between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S, both for primary and secondary technology transfer activities, with a focus on Process validation and all the propaedeutic activities;
• Finalize the industrialization of new products within the R&D Product Teams (as a member of the Extended technical team) and structure the industrial Process validation.

You will need to have

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
• 10+ pharmaceutical/biotech industry years in drug product manufacturing, with at least 5 years of experience in respiratory area (inhalation products). Manufacturing/Technology and Analytical Quality/QC
• Fluency in written and verbal communication in English.
• Willingness to travel up to 30%. Business trips may not be required at all times, travel frequency can vary depending on project/business needs.

We would prefer for you to have

• Direct experience on DPI or pMDI products.
• Direct and solid experience in Process Validation and Lifecycle Management activities.
• Experience working in multicultural and multinational environments.
• Experience working within a CRO or CMO environment.

Soft Skills

• Ability to lead cross-functional project teams in an international environment, including internal and external manufacturing (CMOs/CDMOs).
• Work and think in a proactive way to support business continuity.
• Strong interpersonal skills and ability to interact with different stakeholders.

Location

The primary work location is Parma (Italy). The role offers flexibility, combining on‑site presence with remote work.