Senior Project Technical Manager
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
Build and own the overall CMC development strategy and long-term plan
Manage external consultants and relationships with CMOs/CROs
Oversee project budgets for CMC activities
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
- English fluency
- Proficiency with MS Office
- Broad development/manufacturing experience in CGT, biologics and/or small molecules
- IMP supply planning
Retribuzione / Benefits
annual premio scheme
comprehensive benefits package
remote work options
relocation support
private medical insurance
Build and own the overall CMC development strategy and long-term plan
Manage external consultants and relationships with CMOs/CROs
Oversee project budgets for CMC activities
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
- English fluency
- Proficiency with MS Office
- Broad development/manufacturing experience in CGT, biologics and/or small molecules
- IMP supply planning