Technical Leader Sterile Products & Large Molecules (Process Validation & Life Cycle Management)
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. 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 Benefit 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.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants:
Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.
In 2024, a new Biotech Centre of Excellence has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.
Blois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.
Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).
In 2025, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.
This is what you will do
You will act as the global technical reference for sterile biotech products, ensuring technical robustness throughout the product lifecycle and delivering innovative, compliant solutions supporting the business and Quality organization.
You will contribute to the definition and execution of the industrialization strategy for new products within the R&D Product Teams, acting as a member of the Extended Technical Team. You will structure, plan, and coordinate industrial process validation activities to ensure robust and compliant manufacturing processes. In addition, you will provide technical leadership for lifecycle management projects concerning established products, overseeing the technical assessment and implementation of modifications to critical components, including APIs, excipients, devices, and packaging materials.
You’ll be responsible for:
- Leading and overseeing Technology Transfer activities from R&D or external partners to Chiesi Group manufacturing sites or third-party subcontractors managed by Global Tech Op&S, with a strong focus on process validation.
- Coordinating Product Technical Teams and/or contributing actively to cross-functional workstreams and development meetings to ensure alignment and timely execution of project milestones.
- Providing technical leadership for Industrial Management projects related to products within the established portfolio, particularly in the case of production site transfers or changes to critical components.
- Reviewing and approving technical protocols and reports, as well as bills of materials and material master data within the company information systems.
- Supporting Program Managers,product team in the preparation of key deliverables and updates for governance bodies (e.g., TRB-PRB , Global Tech Op&S, Leadership Team), including lifecycle management activities and business cases.
- Collaborating with Virtual Plant Managers and Procurement to define the technical content of commercial agreements.
- Participating in due diligence activities for multidisciplinary projects, as required.
- Contributing to the global harmonization of biotech sterile manufacturing processes in collaboration with relevant stakeholders (Gloabal-Sites QA-Regulatory-Audit-Sterility assurance).
- Performing product Sustainability Assessments and defining improvement plans.
You will need to have
- Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- 10+ pharmaceutical/biotech industry years in drug product manufacturing, with experience in aseptic processing. Manufacturing/Technology and Analytical Quality/QC
- 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
- Experience working in multicultural and multinational environments.
- Experience working within a CRO or CMO environment.
Technical Skills
- Demonstrated strength in project management, 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 Biotech sterile products manufacturing.
- Experience in pharmaceutical or biotech MSAT process development and/or GMP manufacturing.
- Strong working knowledge of current regulations, quality expectations, and industry trends related to sterile manufacturing and testing.
Soft Skills
- Ability to lead cross-functional project teams in an international environment, including internal and external manufacturing (CMOs/CDMOs).
- Strong interpersonal skills and ability to interact with different stakeholders.
Location
What we offer
No 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.
We 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.
Chiesi 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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