Upstream Biological Process, Lead Scientist; Parma, IT

Position: Upstream Biological Process, Lead Scientist (Parma, IT)
About us  Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

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Global Technical Operations & Supply  Global Technical Operations & Supply (Global Tech Op&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global Tech Op&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement.

This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.
This is what you will do  This role is a senior leadership position responsible for driving the industrialization and lifecycle management of upstream biopharmaceutical processes as individual contributor. It focuses on leading process in sourcing, technology transfer, scale‑up, and validation activities to ensure robust, scalable, and compliant manufacturing from development through commercial production.
The position acts as a key interface across R&D, CDMOs, Production, Quality, and Engineering, coordinating process development, optimization, and characterization while applying Quality by Design (QbD) principles and ensuring alignment with global regulatory expectations (FDA, EMA, ICH).
The role requires strong scientific and technical expertise in upstream biologics, combined with hands‑on leadership in pilot and commercial environments. It also involves supporting regulatory submissions, managing process risks and deviations, and enabling continuous improvement and operational excellence.
A critical component is influencing cross‑function teams, translating complex data into strategic decisions, and building robust product know‑how as a competitive advantage. The role contributes directly to organizational transformation by strengthening industrial capabilities and ensuring successful delivery of biologics programs in a dynamic global setting.
You will be responsible for   Providing hands‑on scientific and technical leadership in process in sourcing, technology transfer, scale‑up, and validation activities, ensuring robust, scalable, and compliant biopharmaceutical manufacturing processes.
Coordinating upstream process development, optimization, and industrialization activities with internal R&D teams and external CMOs.
Leading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability.
Assessing and interpreting complex scientific data to support decision‑making, risk mitigation, resource allocation, and program strategy.
Applying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans.
Supporting regulatory submissions (MAA, NDA, BLA, JNDA) and representing CMC process‑related topics during interactions with health authorities.
Designing, executing, and evaluating pilot‑scale studies to support process development, optimization, scale‑up, and technology transfer activities.
Collaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation.
Supporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports.
Providing technical expertise for investigations, process deviations, change controls, and CAPAs, ensuring effective resolution and continuous process…