Technology Transfer Specialist Lazio

Technology Transfer Specialist
Roma
Lazio, Lazio

Job PurposeWe are seeking a highly motivated Technology Transfer Specialist to coordinate and support the process transfer activities between sending and receiving sites which can be either internal or external (CDMO) to the organization.

The position requires good knowledge of most primary pharmaceutical manufacturing processes (oral, semisolid, liquid and sterile dosage forms).

Additionally, pro-active cooperation and clear communication with colleagues at Recordati and the external partner is essential. Key ResponsibilitiesProject managing the technology transfer and related activities of drug products, drug substances and analytical methods ensuring the successful delivery in terms of quality, costs and time. Handling and reviewing initial quotes, defining technology transfer costs and monitoring of the approved budget.

Working closely with key functions (procurement, finance, supply chain, regulatory, quality) to define transfer strategy and develop business cases. Collecting information from different sources and incorporating into activity reports and action plans. Communicating on project or transfer status, decisions, prioritizations, and delivering presentations to internal stakeholders and external partners. Acting as a focal point in defining the project scope and preparation of the technology transfer plans, setting project deliverables and associated timelines. Supporting the process of identifying, analyzing and responding to any risk that arises over the life cycle of the technology transfer. Generating / reviewing technology transfer documentation as: Request for Proposal, Technology Transfer Plan/Scope, Project Timeline, Technical / GAP assessment, Technology Transfer Report. Reviewing relevant technical documents associated with technology transfer (process validation protocols/reports, manufacturing batch records, analytical protocols /reports)Required EducationDegree educated to BSc or higher within a scientific discipline (Chemistry, Pharmacy, Pharmaceutical Sciences, Biology, Industrial engineering)Required Skills and ExperiencePrevious work experience in Pharma IndustriesAnalytical abilities with detail orientationKnowledge of GMP pharmaceutical processes and scale-up and guidelines/regulations. Technical Competencies5/6 years of experience in the project management of technology transfers. Knowledge of GMP pharmaceutical processes and scale-up and guidelines/regulations. Hands-on experience in writing, reviewing and approving process, analytical protocols, reports and regulatory justifications for variations or submissions related to these subjects. Proven computer proficiency with Microsoft Office programs and database management skillsGood communication skills. Required Behaviours and CompetenciesProactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Required LanguagesFluent in English Travel required in %20-30%