Upstream Biological Process, Lead Scientist

ph3Upstream Biological Process, Lead Scientist /h3 pDate: 2 Jul 2026 /p pBusiness Area: Industrial Operations HSE /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p h3About us /h3 pChiesi 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. Discover more here. /p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /p h3Global Technical Operations Supply /h3 pGlobal Technical Operations Supply (Global TechOpS) 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 TechOpS 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. /p h3This is what you will do /h3 pThis role is a senior leadership position responsible for bdriving the industrialization and lifecycle management of upstream biopharmaceutical processes as individual contributor /b. 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. /p pThe position acts as a key interface across RD, 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). /p pThe role requires bstrong scientific and technical expertise in upstream biologics, combined with hands‑on leadership in pilot and commercial environments /b. It also involves supporting regulatory submissions, managing process risks and deviations, and enabling continuous improvement and operational excellence. /p pA 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 organisational transformation by strengthening industrial capabilities and ensuring successful delivery of biologics programmes in a dynamic global setting. /p h3You will be responsible for /h3 ul liProviding hands‑on scientific and technical leadership in process insourcing, technology transfer, scale‑up, and validation activities, ensuring robust, scalable, and compliant biopharmaceutical manufacturing processes. /li liCoordinating upstream process development, optimisation, and industrialisation activities with internal RD teams and external CMOs. /li liLeading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance and supply reliability. /li liAssessing and interpreting complex scientific data to support decision‑making, risk mitigation, resource allocation and programme strategy. /li liApplying and promoting Quality by Design (QbD) principles and contributing to process characterisation, control strategies and validation plans. /li liSupporting regulatory submissions (MAA, NDA, BLA, JNDA) and representing CMC process‑related topics during interactions with health authorities. /li liDesigning, executing and evaluating pilot‑scale studies to support process development, optimisation, scale‑up and technology transfer activities. /li liCollaborating with Production, Quality, Engineering and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ) and commercial process implementation. /li liSupporting the development of GMP documentation, including batch records, risk assessments, validation protocols and technical reports. /li liProviding technical expertise for investigations, process deviations, change controls and CAPAs, ensuring effective resolution and continuous process improvement. /li liDelivering theoretical and practical training to Manufacturing personnel to ensure compliant and efficient execution of commercial production processes. /li /ul h3You will need to have /h3 ul liMSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry or a related discipline. /li liAt least 10 years of experience in biopharmaceutical drug substance process development, with a proven track record of leadership in complex biologics CMC programmes. /li liStrong scientific background in biologics manufacturing and bioprocess development. /li liDeep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single‑use bioreactors, centrifugation and depth filtration. /li liProven experience in process optimisation, scale‑up/down activities, technology transfer and industrialisation of biotechnological products. /li liSolid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH and CMC guidelines. /li liExperience supporting regulatory submissions and managing manufacturing processes in FDA‑ and EMA/AIFA‑approved facilities. /li liDemonstrated ability to manage CDMO partnerships and external development activities. /li liStrong understanding of product lifecycle management and commercialisation strategies for biologics. /li liGood knowledge of English (written and spoken). /li liAdvanced analytical and problem‑solving skills, with the ability to synthesize complex datasets into actionable insights. /li liProven leadership capability, with good communication skills and the ability to influence across all organisational levels. /li liExcellent collaboration skills with personnel from different company functions. /li liAbility to work on multiple projects while meeting agreed deadlines. /li liAbility to work in a dynamic and global environment. /li liWillingness to travel if necessary. /li /ul h3Location /h3 pParma /p h3Other /h3 pThe minimum salary for this role is €62,000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme and flexible benefits programme. /p h3What we offer /h3 pNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p pWe provide top‑class benefits, including comprehensive healthcare programmes, work‑life balance initiatives and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options and tax assistance services for foreign colleagues, all designed to help you thrive. /p pChiesi is an equal‑opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination. /p /p #J-18808-Ljbffr