CMC Program Lead - Biotech (Hybrid, Italy)

Barrington James; Milano; Ibrido; EUR 60.000 - 110.000; Tempo pieno

Descrizione del lavoro

Barrington James is seeking an experienced CMC Manager in Italy to lead Chemistry, Manufacturing and Controls across development programmes. This role combines strategic oversight with hands-on management of external development and manufacturing activities in a biotech setting.

The successful candidate will drive CMC strategy, ensure regulatory alignment with FDA/EMA guidelines, and oversee collaboration with cross-functional teams to progress assets through clinical development and regulatory

Competenze

• 8–10 years of experience in CMC development and manufacturing.
• Experience managing outsourced CMC activities with external partners (GMP).
• Knowledge of FDA, EMA, and ICH CMC requirements.
• Strong project management and stakeholder management skills.

Mansioni

• Lead and coordinate CMC activities across development programmes and external manufacturing.
• Oversee drug substance and drug product manufacturing and stability programmes.
• Manage relationships with external CDMO/CMO partners and ensure timely delivery of materials.
• Provide CMC input to regulatory strategy and documentation.

Conoscenze

CMC strategy

Regulatory affairs

Project management

Cross-functional collaboration

Vendor management

Formazione

Master’s or PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field

Descrizione del lavoro

Barrington James is seeking an experienced CMC Manager in Italy to lead Chemistry, Manufacturing and Controls across development programmes. This role combines strategic oversight with hands-on management of external development and manufacturing activities in a biotech setting.

The successful candidate will drive CMC strategy, ensure regulatory alignment with FDA/EMA guidelines, and oversee collaboration with cross-functional teams to progress assets through clinical development and regulatory