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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.

As a Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger.

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 insourcing, 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 (Qb D) 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-functional 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 insourcing, 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. 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 improvement. Delivering theoretical and practical training to Manufacturing personnel to ensure compliant and efficient execution of commercial production processes. You will need to have MSc or Ph D in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.

At least 10 years of experience in biopharmaceutical drug substance process development, with a proven track record of leadership in complex biologics CMC programs. Strong scientific background in biologics manufacturing and bioprocess development. Deep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single-use bioreactors, centrifugation, and depth filtration.

Proven experience in process optimization, scale-up/down activities, technology transfer, and industrialization of biotechnological products. Solid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines.

Experience supporting regulatory submissions and managing manufacturing processes in FDA- and EMA/AIFA-approved facilities. Strong understanding of product lifecycle management and commercialization strategies for biologics. Good knowledge of English (written and spoken).

Proven leadership capability, with good communication skills and the ability to influence across all organizational levels. Excellent collaboration skills with personnel from different company functions; Ability to work on multiple projects while meeting agreed deadlines; Ability to work in a dynamic and global environment;

📌 Upstream biological process, lead scientist (Parma)
🏢 Chiesi
📍 Parma