ph3About us /h3pChiesi 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.
At 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 Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity 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.
/ph3Global Technical Operations Supply /h3pGlobal 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.
/ph3What you will do /h3pThis 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 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).
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.
/ph3You will be responsible for /h3ulliProviding hands?on scientific and technical leadership in process insourcing, technology transfer, scale?up, and validation activities, ensuring robust, scalable, and compliant biopharmaceutical manufacturing processes.
/liliCoordinating upstream process development, optimization, and industrialization activities with internal RD teams and external CMOs.
/liliLeading lifecycle management activities for commercial biotech processes, ensuring continuous improvement, process robustness, compliance, and supply reliability.
/liliAssessing and interpreting complex scientific data to support decision?making, risk mitigation, resource allocation, and program strategy.
/liliApplying and promoting Quality by Design (QbD) principles and contributing to process characterization, control strategies, and validation plans.
/liliSupporting regulatory submissions (MAA, NDA, BLA, JNDA) and representing CMC process?related topics during interactions with health authorities.
/liliDesigning, executing, and evaluating pilot?scale studies to support process development, optimization, scale?up, and technology transfer activities.
/liliCollaborating with Production, Quality, Engineering, and Maintenance functions to support feasibility studies, validation campaigns, equipment qualification (IQ/OQ/PQ), and commercial process implementation.
/liliSupporting the development of GMP documentation, including batch records, risk assessments, validation protocols, and technical reports.
/liliProviding technical expertise for investigations, process deviations, change controls, and CAPAs, ensuring effective resolution and continuous process improvement.
/liliDelivering theoretical and practical training to Manufacturing personnel to ensure compliant and efficient execution of commercial production processes.
/li /ulh3You will need to have /h3ulliMSc or PhD in Biotechnology, Biochemical Engineering, Biochemistry, or a related discipline.
/liliAt least 10 years of experience in biopharmaceutical drug substance process development, with a proven track record of leadership in complex biologics CMC programs.
/liliStrong scientific background in biologics manufacturing and bioprocess development.
/liliDeep expertise in upstream process development and manufacturing, including mammalian cell culture (preferably CHO), single?use bioreactors, centrifugation, and depth filtration.
/liliProven experience in process optimization, scale?up/down activities,



technology transfer, and industrialization of biotechnological products.
/liliSolid knowledge of GMP requirements and global regulatory frameworks, including FDA, EMA, ICH, and CMC guidelines.
/liliExperience supporting regulatory submissions and managing manufacturing processes in FDA?and EMA/AIFA?approved facilities.
/liliDemonstrated ability to manage CDMO partnerships and external development activities.
/liliStrong understanding of product lifecycle management and commercialization strategies for biologics.
/liliGood knowledge of English (written and spoken).
/li /ulh3Leadership Competencies /h3ulliAdvanced analytical and problem?solving skills, with the ability to synthesize complex datasets into actionable insights.
/liliProven leadership capability, with good communication skills and the ability to influence across all organizational levels.
/liliExcellent collaboration skills with personnel from different company functions.
/liliAbility to work on multiple projects while meeting agreed deadlines.
/liliAbility to work in a dynamic and global environment.
/liliWillingness to travel if necessary.
/li /ulh3Location /h3pParma /ph3Compensation Range /h3pThe minimum salary for this role is ******, aligned to our established salary framework.
The final offer will reflect the candidate's skills, experience, qualifications and internal equity considerations.
This role is eligible to participate in an annual bonus scheme, subject to company and individual performance.
In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme.
/ph3What we offer /h3pNo 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.
/ppWe provide top?class benefits, including comprehensive healthcare programs, 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.
/ph3Equal opportunity /h3pChiesi 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.
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📌 Upstream Biological Process, Lead Scientist (Parma)
🏢 Chiesi
📍 Parma