18 set - Parma
Chiesi Farmaceutici
Business Area: R&D;, Pharmacovigilance & Regulatory Affairs
Contract Type: Permanent
Parma, IT
Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
We believe our differences make us stronger. Chiesi Global Rare Diseases
Chiesi 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.
This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma.
Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. GRD 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.
The CMC director hold the role of technical leader on the CT and the ETT.
The CMC director can also hold the role of ETT workstream lead depending on the project deliverables.
Build the overall strategic development plan incollaboration with product CT.
Strategy of the CMC development including IMPsupply to meet the project milestones and longterm business objectives.
Drive execution of the CMC development plan incompliance with the regulatory strategy.
Coordinate building of documentation package fitfor development phase.
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