Senior Global SME PV&LCM

This is what you will do
You will act as Subject Matter Expert for Process Validation and technical maintenance activities, supporting industrialization, product technology transfer and life cycle management for Respiratory, Orals & Small Molecules products.
You will provide specialist technical support to R&D, Operations, Quality and external stakeholders, including contract manufacturers and subcontractors, ensuring robust and compliant manufacturing processes throughout the product lifecycle. As part of R&D Product Teams and the Extended Technical Team, you will support industrial process validation activities and coordinate technical maintenance on in-market products, contributing to solutions aligned with Quality requirements and business needs.
You will be responsible for

Participating to Technology transfer process between different Chiesi group sites (R&D included) and/or subcontractors operated by Global TechOP&S with a focus on Process validation and all the propaedeutic activities
Collaborating in designing TT documents and matrix, supporting the identification of scientific rationales to be reported in quality and regulatory documentation
Finalizing the industrialization of new products within the R&D Product Teams (as a member of the Extended technical team) and to structure the industrial Process validation
Executive responsibility 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
Scouting for new equipment/technologies and tools to improve manufacturing execution and process robustness
Being the key reference person for Global TechOP&S functions (incl. plant Site Process SME - Parma, Blois, Santana, Nerviano 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 X maintenance
Being the key reference person in Global TechOP&S functions for product lifecycle, reporting to dedicated governance bodies.
Supporting Chiesi functions (Global and Local) in preparation to audits (inspection readiness streams)
Partecipating constructively or coordinate Extended Teams and work packages development meetings (e.g., ETTs, Technical Maintenance, Operative Teams…)
Supporting the development and evolution of Chiesi products toward sustainability-driven initiatives, through the Ecofriendly challenge and perform product Sustainability Assessment and define improvement plans
Providing scientific evaluation and effective methodological support in problem solving, contributing in a significative way to identify root causes.
Participating constructively to the Extended Teams for Task forces

You will need to have

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
5+ pharmaceutical/biotech industry years in drug product manufacturing, with at least 3 years of experience in a similar role or in Manufacturing/Technology and Analytical Quality/QC area.
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 respiratory products (DPI and/or pMDI) and/or oral solid and small molecules.
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.

Technical Skills

Demonstrated strength in problem‑solving, and interpersonal communication, with a proven ability to work effectively across diverse technical, business, and operational functions.
Solid understanding of the pharmaceutical industry and end‑to‑end drug products manufacturing.
Experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing.
Strong working knowledge of…