For a solid European Pharmaceutical Contract Development and Manufacturing Organization (CDMO), part of an established international manufacturing group with a long‑standing industrial heritage and operating in Italy with a manufacturing site located in the Lombardy region, we are looking for an experienced professional to fill the position of:
Head of Manufacturing
Main responsibilities
Reporting directly to the Plant Director, the role will have a key responsibility in leading manufacturing operations within the Solid Oral Dosage Forms Department, ensuring the efficient, compliant, high-quality and timely production of tablets, capsules, and other solid oral pharmaceutical products, as well as overseeing the successful transfer of new products into manufacturing.
Main Responsibilities
- Oversee daily manufacturing activities for solid oral dosage forms, ensuring adherence to GMP and regulatory standards;
- Lead and manage a team of shift supervisors and MFG operators to meet production targets;
- Be accountable for all Technology Transfer Programs;
- Collaborate with Quality Assurance, Engineering, Maintenance and Supply Chain to optimize processes and resolve operational issues;
- Collaborate with EHS to ensure full-compliance of Safety standard in the department, acting as the appointed Safety Supervisor (Preposto) for the area;
- Monitor KPIs such as yield, efficiency, downtime, and quality deviations; implement corrective actions as needed;
- Ensure accurate and compliant documentation (MBR) produced by the manufacturing department and manage all related ERP transactions for finished product delivery;
- Drive continuous improvement initiatives and ensure their effective implementation;
- Ensure proper training and professional development of team members;
- Participate in audits and inspections by clients and regulatory authorities;
- Manage departmental capacity planning and resource allocation.
Candidate profile
- University Degree in Pharmaceutical Chemistry and Technology (CTF), Chemistry, Engineering or a related field;
- Proven experience in pharmaceutical manufacturing, with at least 2 years in a leadership role;
- Strong knowledge of GMP, AIFA, EMA, and other relevant regulatory guidelines;
- Proven experience with solid oral dosage technologies (granulation, compression, coating, encapsulation);
- Project management experience in Technology Transfer Programs;
- Excellent leadership, communication, and problem-solving skills;
- Fluent in English.
Location
Lombardy Region. The position is regularly based on Site.