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.
Structure, plan, and coordinate industrial process validation activities to ensure robust and compliant manufacturing processes.
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 and 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
The primary work location is Parma (Italy). The role offers flexibility, combining on‑site presence with remote work, and may allow working from other strategic European locations.
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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