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Bracco · 3 months ago

Project Manager - API (Active Pharmaceutical Ingredients)

ITA - Milano - Via Egidio Folli

Full-time

Hybrid

Senior Level

5+ years exp

Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Project Manager - API will be responsible for planning, managing, and supervising complex projects related to facilities for the production of Active Pharmaceutical Ingredients (APIs). This role involves close interaction with stakeholders and adherence to GMP requirements and regulatory standards.

Health CareHealth DiagnosticsMedical

Responsibilities

Coordinate development, expansion, or revamping projects of API facilities, including pilot plants and production lines

Manage design, procurement, commissioning, and qualification phases (FAT, SAT, IQ/OQ) of facilities and automation systems

Collaborate with cross-functional teams (engineering, quality, manufacturing, suppliers) to ensure regulatory and technical compliance

Monitor project progress in terms of timelines, costs, and quality, ensuring achievement of established milestones

Coordinate permitting activities required to obtain authorizations for construction phases

Supervise technical and validation documentation through dedicated teams

Support the transition to routine production and address potential operational issues

Qualification

GMP regulationsPharmaceutical projectsProject management toolsChemical synthesisProcess control systemsProfessional certificationsEnglish languageItalian languageCommunication skillsProblem-solving skillsOrganizational skills