Manufacturing Science & Technology Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/792a0p

pDompé 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. /ppOur 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. /ppbr/ppIn this context, we are looking for a strongManufacturing Science Technology Specialist /strong 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 RD 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. /ppbr/ppstrongResponsibilities: /strong /pulliLead the technology transfer projects by technical standpoint for products already /liliregistered, acting as Project Leader for the assigned projects; /liliPlan and manage the assigned projects in terms of timelines, costs and resources, ensuring /lilithat milestones and deliverables are met; /liliPrepare and maintain the periodic project reporting on progress, risks and key performance /liliindicators for management and stakeholders; /liliAddress, in agreement with the line manager, the technical feasibility of new products /liliincluding the scale up at industrial level,



Process Validation pre and post registration; /li /ulpLife Cycle Management /pulliImplement and / or participate in existing product maintenance projects or LCM initiatives /lilifor recurring issues or collaborate on the introduction of new suppliers / third parties providers; /liliPerform studies related 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); /liliContribute to product cost reduction by proposing and implementing more performant manufacturing processes; /liliPropose corrective and preventive measures to improve process robustness by developing, with the possible support of other functions, feasibility studies and related technical / economic analysis; /li /ulpTechnical Batches, Validation Documentation – Support to Deviations and Registrations /pulliPerform Process Validation for new product, process or equipment; /liliPerform scale up studies and technical batches on industrial scale, being responsible for the related technical decisions; /liliDraft the key technical documentation for validation and technology transfer activities (process URS, protocols, reports and transfer plans, FMEA, process risk analysis, IPC trend analysis ); /liliProvide Technical and Scientific support during the preparation of the CTD/NDA/BLA Registration Technical Part; /liliSupport Quality team during Audits performed by partners or regulatory authorities as subject matter expert on technical aspects; /liliCollaborate with the functions involved in resolving deviations and non-conformities; /liliBe aware and act in compliance with the relevant law, ethics and regulations and corporate procedures of the reference area. /li /ulpbr/ppstrongQualifications:



/strong /pulliDegree in a scientific or technical discipline (Pharmaceutical Chemistry and Technology, Pharmacy, Chemistry, Biotechnology, Engineering, or equivalent). /lilistrongAt least 3 years of experience /strong in Manufacturing Science Technology, Process Development, Industrialization, or Technology Transfer roles within the pharmaceutical or biotech industry. /liliSolid experience in Technology Transfer, Scale-Up, and Process Validation activities. /liliKnowledge of pharmaceutical manufacturing processes, with a particular focus on: /liliSterile manufacturing processes; /liliBiotech processes and technologies. /liliKnowledge of GMP requirements and key regulatory standards. /liliAbility to work effectively in cross-functional teams and manage multidisciplinary projects. /liliExcellent command of both Italian and English. /li /ulpbr/ppstrongPreferred Qualifications: /strong /pulliMaster's degree or specialized training in Technology Transfer, Process Development, or related fields. /liliProject Management certifications (PMP, PRINCE2, CAPM, or equivalent). /liliExperience managing investment, industrialization, or new facility/production line implementation projects. /li /ulpbr/ppstrongWhat We Offer: /strong /pulliContract type: permanent employment contract, governed by the National Collective Labour Agreement for the Chemical-Pharmaceutical Industry (CCNL Chimico-Farmaceutico) /liliGross annual salary (RAL): starting from € strong45,000 /strongper 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 /liliIncentive system: an economic incentive is provided based on the company's existing reward system. /liliRelocation premio /liliThe opportunity to work in a highly innovative environment and contribute to strategic projects supporting Dompé's industrial and technological growth. /liliA dynamic, international, and people-focused workplace where you can make a tangible impact on pharmaceutical and biotech innovation. /li /ulpbr/ppIf 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. strongJoin us and help shape the future of pharmaceutical innovation. /strong /p

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/792a0p