Descrizione dell'offerta
Dompé is an Italian biopharmaceutical company internationally recognized for its commitment to the research and development of innovative therapies with high therapeutic value. For over 130 years, we have been transforming cutting-edge science into meaningful solutions for patients, leveraging breakthrough biotechnology, advanced digital capabilities, and world-class expertise to address unmet medical needs.
Our L'Aquila manufacturing site is at the center of an ambitious transformation journey, becoming a hub for the adoption and scaling of next-generation biotech platforms and advanced manufacturing technologies. The site is driving the industrialization of innovative biologics emerging from the development pipeline while expanding its manufacturing capabilities through significant investments in automation, digitalization, data-driven processes, and state-of-the-art biotechnology solutions. This evolution positions L'Aquila as a key contributor to Dompé's innovation strategy and future growth.
Per il seguente ruolo potrebbero essere richieste diverse soft skill ed esperienze. La preghiamo di consultare attentamente la panoramica riportata di seguito.
In this context, we are looking for a
Manufacturing Science & Technology Specialist
who will play a pivotal role in advancing the industrialization of innovative biotech products and technologies. Leading Process Development and Technology Transfer projects across Dompé's manufacturing network and external partners, the successful candidate will work at the intersection of R&D innovation and manufacturing excellence, driving the scale-up of new biotech molecules from development to commercial production. This role offers a unique opportunity to contribute to the implementation of cutting-edge manufacturing platforms, accelerate technology adoption, and shape the future of biotech manufacturing through continuous innovation and operational excellence.
Responsibilities: Lead the technology transfer projects by technical standpoint for products already registered, acting as Project Leader for the assigned projects;
Plan and managethe assigned projects in terms of timelines, costs and resources, ensuring that milestones and deliverables are met;
Prepare and maintain the periodic project reporting on progress, risks and key performance indicators for management and stakeholders;
Address, in agreement with the line manager, the technical feasibility of new products including the scale up at industrial level, Process Validation pre and post registration;
Life Cycle Management Implement and / or participate in existing product maintenance projects or LCM initiatives for recurring issues or collaborate on the introduction of new suppliers / third parties providers;
Perform studiesrelated to changes of the critical components of the products (e.G. API, excipients, primary packaging) and manufacturing processes (e.G. batch size increase, process optimization, change of critical equipment) due to external factors (e.G. suppliers, cost reductions or business continuity);
Contribute to product cost reduction by proposing and implementing more performant manufacturing processes;
Propose corrective and preventive measures to improve process robustness by developing, with the possible support of other functions, feasibility studies and related technical / economic analysis;
Technical Batches, Validation & Documentation – Support to Deviations and Registrations Perform Process Validation for new product, process or equipment;
Perform scale up studies and technical batches on industrial scale, being responsible for the related technical decisions;
Draft the key technical documentation for validation and technology transfer activities (process URS, protocols, reports and transfer plans, FMEA, process risk analysis, IPC trend analysis );
Provide Technical and Scientific support during the preparation of the CTD/NDA/BLA Registration Technical Part;
Support Qualityteam during Audits performed by partners or regulatory authorities as subject matter expert on technical aspects;
Collaborate with the functions involved in resolving deviations and non-conformities;
Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area.
Qualifications: Degree in a scientific or technical discipline (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology, Engineering, or equivalent). At least 3 years of experience
in Manufacturing Science & Technology, Process Development, Industrialization, or Technology Transfer roles within the pharmaceutical or biotech industry. Solid experience in Technology Transfer, Scale-Up, and Process Validation activities. Knowledge of pharmaceutical manufacturing processes, with a particular focus on: Sterile manufacturing processes;
Biotech processes and technologies. Knowledge of GMP requirements and key regulatory standards. Ability to work effectively in cross-functional teams and manage multidisciplinary projects. Excellent command of both Italian and English.
Preferred Qualifications: Master's degree or specialized training in Technology Transfer, Process Development, or related fields. Project Management certifications (PMP, PRINCE2, CAPM, or equivalent). Experience managing investment, industrialization, or new facility/production line implementation projects.
What We Offer: Contract type: permanent employment contract, governed by the National Collective Labour Agreement for the Chemical-Pharmaceutical Industry (CCNL Chimico-Farmaceutico) Gross annual salary (RAL): starting from €
45,000
per year, determined on the basis of objective and gender-neutral criteria and commensurate with the candidate's profile and experience, technical competencies, the level of autonomy and responsibility required for the role, and consistency with the company's remuneration Incentive system: an economic incentive is provided based on the company's existing reward system. Relocation bonus The opportunity to work in a highly innovative environment and contribute to strategic projects supporting Dompé's industrial and technological growth. A dynamic, international, and people-focused workplace where you can make a tangible impact on pharmaceutical and biotech innovation. xpavfwm
If you are eager to apply your expertise to innovative projects and make a difference in a fast-evolving environment, we would be delighted to hear from you.
Join us and help shape the future of pharmaceutical innovation.
Per il seguente ruolo potrebbero essere richieste diverse soft skill ed esperienze. La preghiamo di consultare attentamente la panoramica riportata di seguito.
In this context, we are looking for a
Manufacturing Science & Technology Specialist
who will play a pivotal role in advancing the industrialization of innovative biotech products and technologies. Leading Process Development and Technology Transfer projects across Dompé's manufacturing network and external partners, the successful candidate will work at the intersection of R&D innovation and manufacturing excellence, driving the scale-up of new biotech molecules from development to commercial production. This role offers a unique opportunity to contribute to the implementation of cutting-edge manufacturing platforms, accelerate technology adoption, and shape the future of biotech manufacturing through continuous innovation and operational excellence.
Responsibilities: Lead the technology transfer projects by technical standpoint for products already registered, acting as Project Leader for the assigned projects;
Plan and managethe assigned projects in terms of timelines, costs and resources, ensuring that milestones and deliverables are met;
Prepare and maintain the periodic project reporting on progress, risks and key performance indicators for management and stakeholders;
Address, in agreement with the line manager, the technical feasibility of new products including the scale up at industrial level, Process Validation pre and post registration;
Life Cycle Management Implement and / or participate in existing product maintenance projects or LCM initiatives for recurring issues or collaborate on the introduction of new suppliers / third parties providers;
Perform studiesrelated to changes of the critical components of the products (e.G. API, excipients, primary packaging) and manufacturing processes (e.G. batch size increase, process optimization, change of critical equipment) due to external factors (e.G. suppliers, cost reductions or business continuity);
Contribute to product cost reduction by proposing and implementing more performant manufacturing processes;
Propose corrective and preventive measures to improve process robustness by developing, with the possible support of other functions, feasibility studies and related technical / economic analysis;
Technical Batches, Validation & Documentation – Support to Deviations and Registrations Perform Process Validation for new product, process or equipment;
Perform scale up studies and technical batches on industrial scale, being responsible for the related technical decisions;
Draft the key technical documentation for validation and technology transfer activities (process URS, protocols, reports and transfer plans, FMEA, process risk analysis, IPC trend analysis );
Provide Technical and Scientific support during the preparation of the CTD/NDA/BLA Registration Technical Part;
Support Qualityteam during Audits performed by partners or regulatory authorities as subject matter expert on technical aspects;
Collaborate with the functions involved in resolving deviations and non-conformities;
Be aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area.
Qualifications: Degree in a scientific or technical discipline (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology, Engineering, or equivalent). At least 3 years of experience
in Manufacturing Science & Technology, Process Development, Industrialization, or Technology Transfer roles within the pharmaceutical or biotech industry. Solid experience in Technology Transfer, Scale-Up, and Process Validation activities. Knowledge of pharmaceutical manufacturing processes, with a particular focus on: Sterile manufacturing processes;
Biotech processes and technologies. Knowledge of GMP requirements and key regulatory standards. Ability to work effectively in cross-functional teams and manage multidisciplinary projects. Excellent command of both Italian and English.
Preferred Qualifications: Master's degree or specialized training in Technology Transfer, Process Development, or related fields. Project Management certifications (PMP, PRINCE2, CAPM, or equivalent). Experience managing investment, industrialization, or new facility/production line implementation projects.
What We Offer: Contract type: permanent employment contract, governed by the National Collective Labour Agreement for the Chemical-Pharmaceutical Industry (CCNL Chimico-Farmaceutico) Gross annual salary (RAL): starting from €
45,000
per year, determined on the basis of objective and gender-neutral criteria and commensurate with the candidate's profile and experience, technical competencies, the level of autonomy and responsibility required for the role, and consistency with the company's remuneration Incentive system: an economic incentive is provided based on the company's existing reward system. Relocation bonus The opportunity to work in a highly innovative environment and contribute to strategic projects supporting Dompé's industrial and technological growth. A dynamic, international, and people-focused workplace where you can make a tangible impact on pharmaceutical and biotech innovation. xpavfwm
If you are eager to apply your expertise to innovative projects and make a difference in a fast-evolving environment, we would be delighted to hear from you.
Join us and help shape the future of pharmaceutical innovation.
Candidatura e Ritorno (in fondo)
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