Senior Technical Leader, GRD CMC

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ppSelect how often (in days) to receive an alert: /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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. /p pAt 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 Vantaggi Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /p pDiversity 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. /p pbChiesi Global Rare Diseases /b /p pChiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. /p pThis unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. /p pRare unit has a focus on research and product development for lysosomal storage diseases, rare hematology,



ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here . /p pbWhat we are looking for /b /p h3bThis is what you will do /b /h3 pGRD Technical Leader is accountable for the budget, strategy and execution of CMC development and IMP supply of projects within the GRD portfolio from candidate nomination/selection to handover to manufacturing organisation for commercial launch. /p pThe CMC director hold the role of technical leader on the CT and the ETT. /p pThe CMC director can also hold the role of ETT workstream lead depending on the project deliverables. /p h3bYou will be responsible for /b /h3 ul liBuild the overall strategic development plan incollaboration with product CT. /li liStrategy of the CMC development including IMPsupply to meet the project milestones and longterm business objectives. /li liDrive execution of the CMC development plan incompliance with the regulatory strategy. /li liCoordinate building of documentation package fitfor development phase. /li liLead new business development opportunityevaluations with focus on CMC. /li liAct as GRD CMC representative in project coreteam. /li liBuild and organize the ETT by sourcing the rightinternal and external competences according toproject needs. /li liLead and manage external consultants.



/li liLead the ETT based on the project scope andstrategic development plan. /li liProject budget accountability for CMC activities(CRO’s, CDMOs, main consultancy agreementsetc). /li liAct as subject matter expert in areas ofcompetence /li liAct as workstream lead depending on projectrequirements. /li liReview the ETT workstreams development plansand align it with the overall strategic developmentplan. /li liProviding technical support in scouting, auditing,and selection of CROs/CDMOs. /li liLead and manage long term relationships withacademic partners/CRO/CDMOs for successfuldelivery of collaboration and outsourced projectswith Chiesi values and shared value in mind. /li liProvide technical review and approval, if neededand as seen fit, of relevant documentation toachieve proper quality for clinical trial applicationsand market approval applications /li liActively contribute and drive the development ofthe department in line with GRD and GRD RDstrategic goals. /li liDisseminate technical knowledge and leadershipskills within department and to relevant adjacentfunctions throughout Chiesi. /li /ul h3bYou will need to have /b /h3 ul liMinimum Master of Science in relevant field /li liMinimum 10 years of relevant industrial experience from the pharmaceutical industry. /li liExperience from development or manufacturing of drug substances, drug products or medical devices. /li liHighly experienced in leading and managing internal and external activities, resources, and stakeholders. /li liExperience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements. /li liExperience from working with CMOs and CROs. /li liGood knowledge regarding GMP compliance. /li liGood knowledge of drug development framework including regulatory

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8lm1be