Senior Technical Leader, Grd Cmc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ooh3j

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 align with regulatory strategy and long-term business objectives.
This role offers impact in rare disease research and collaborations that shape development programs.
Retribuzione / Benefits
annual premio scheme
comprehensive benefits package
remote work options
relocation support
private medical insurance
wellbeing programme
Responsabilità
Build and own the overall CMC development strategy and long-term plan
Drive execution of CMC activities in line with regulatory strategy
Coordinate documentation packages for development phases
Lead ETT workstreams and assemble required internal/external competencies
Manage external consultants and relationships with CMOs/CROs




Oversee project budgets for CMC activities
Provide SME input for regulatory submissions and quality documentation
Mentor team members and disseminate technical knowledge across GRD and adjacent functions
Requisiti fondamentali
Master of Science in relevant field
?10 years of pharmaceutical industry experience
Experience in development/manufacturing of drug substances/products or medical devices
Strong leadership and stakeholder management
Regulatory interaction experience with EMA/FDA and ICH/GMP knowledge
Experience with CMOs/CROs and GMP compliance
Excellent written and verbal communication; English fluency
Proficiency with MS Office
Broad development/manufacturing experience in CGT, biologics and/or small molecules
leadership
problem-solving
clear communication
CMC development
IMP supply planning
regulatory strategy and submissions

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ooh3j