Sterile Biologics Production Lead - Site Start-Up

Chiesi Farmaceutici S.p.A.; Milano; In loco; EUR 35.000 - 43.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension plan

Private medical insurance

Wellbeing programme

Flexible benefits

Relocation assistance

Remote work options

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Milan is seeking an experienced Sterile Production Supervisor to join a greenfield biologics operation.

You will oversee aseptic processing, participate in design, start-up, and qualification activities, and ensure GMP compliance in a site built from the ground up. The role focuses on leading operations, maintaining cleanliness, training staff, and driving continuous improvement while collaborating with MS&T, Engineering, QA and Validation teams.Competitive benefits

Competenze

• Degree in Biotechnology, Pharmacy, Biology, Chemical Engineering, or related scientific disciplines.
• 3-5 years of experience in sterile pharmaceutical manufacturing.
• Proven hands-on experience in biologics manufacturing (e.g., aseptic processing, sterile filtration, fill-finish, upstream/downstream interfaces).
• Knowledge of GMP and Annex 1 requirements.
• Deep understanding of aseptic techniques and contamination control strategy.
• Familiarity with process validation and equipment qualification.
• Strong documentation and deviation management capabilities.

Mansioni

• Contribute to process and facility design discussions, ensuring manufacturability and GMP compliance.
• Support layout review, equipment URS definition, and operational input during design and procurement phases.
• Participate in FAT/SAT, commissioning, and qualification activities for sterile biologics manufacturing lines.
• Collaborate with MS&T, Engineering, QA, and Validation teams to define robust operational workflows.
• Contribute to the development of SOPs, batch records, training programs, and aseptic practices.

Conoscenze

Sterile production

GMP compliance

Biologics manufacturing

Leadership

Documentation

Formazione

Degree in Biotechnology, Pharmacy, Biology, Chemical Engineering, or related scientific disciplines

Strumenti

Qualification protocols

FAT/SAT participation

Descrizione del lavoro

Chiesi Farmaceutici S.p.A. in Milan is seeking an experienced Sterile Production Supervisor to join a greenfield biologics operation.

You will oversee aseptic processing, participate in design, start-up, and qualification activities, and ensure GMP compliance in a site built from the ground up. The role focuses on leading operations, maintaining cleanliness, training staff, and driving continuous improvement while collaborating with MS&T, Engineering, QA and Validation teams.Competitive benefits