Senior CMC Leader, Biologics

Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Chiesi 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...

Overview In this role you will lead protein biologics drug substance development within GRD CMC, guiding expression systems, upstream/downstream processing, and product quality strategies. You will direct technical teams, shape CMC development plans, and ensure alignment with regulatory and lifecycle needs. Your work directly impacts robust development,...

Overview In this role you will lead protein biologics drug substance development within GRD CMC, guiding expression systems, upstream/downstream processing, and product quality strategies. You will direct technical teams, shape CMC development plans, and ensure alignment with regulatory and lifecycle needs. Your work directly impacts robust development,...

Select how often (in days) to receive an alert: Business Area: R&D, Pharmacovigilance & Regulatory Affairs Job Type: Direct Employee Contract Type: Permanent Location: Parma, IT About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy....

Overview In this role you drive the CMC development strategy, IMP supply planning, and budget for GRD projects from candidate nomination to handover to manufacturing for launch. You act as technical lead for CT and ETT workstreams, coordinating internal and external experts to deliver compliant development packages. You partner with cross-functional teams to...

Overview In this role you drive the CMC development strategy, IMP supply planning, and budget for GRD projects from candidate nomination to handover to manufacturing for launch. You act as technical lead for CT and ETT workstreams, coordinating internal and external experts to deliver compliant development packages. You partner with cross-functional teams...

Overview As a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions,...

Overview In this GRD CMC role, you will shape analytical and CMC strategy for rare disease programs. You will work closely with science and development teams, external partners, and CROs to translate science into robust development plans and compliant execution. You will drive risk-based CMC decisions, lifecycle management, and ensure regulatory alignment...

Overview In this GRD CMC role, you will shape analytical and CMC strategy for rare disease programs. You will work closely with science and development teams, external partners, and CROs to translate science into robust development plans and compliant execution. You will drive risk-based CMC decisions, lifecycle management, and ensure regulatory alignment...