Sterile Drug Process Scientist — Scale-Up & Tech Transfer

ThermoFisher Scientific; Monza; In loco; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

Thermo Fisher Scientific in Monza, Italy, is seeking a Manufacturing Process Scientist to join the PDS team. You will help design, develop and optimize sterile manufacturing processes for clinical and small-scale commercial products, and lead process transfer to cGMP manufacturing suites at Monza.

The role emphasizes scientific leadership, collaboration with cross-functional teams, and close client partnership to deliver robust, compliant manufacturing solutions and ongoing process improvements.

Competenze

• Bachelor's or Master's degree in Pharmacy, Pharmaceutical Chemistry and Technology, Biotechnology, Chemistry, Chemical Engineering, or another relevant scientific discipline.
• 2–3 years of experience in sterile pharmaceutical process development and/or manufacturing.
• 2–3 years of experience with liquid, suspension and/or lyophilized drug products.
• Good knowledge of GMP requirements; GLP is considered an advantage.
• 2–3 years of experience preparing technical documentation such as manufacturing instructions, study protocols, technical reports, FMEA and GAP analyses.
• Excellent written and verbal communication skills in English.

Mansioni

• Define, develop and optimize manufacturing processes for sterile injectable products based on product knowledge, development data and Quality Target Product Profile (QTPP).
• Prepare and review technical documentation, including manufacturing instructions, study protocols, technical reports, FMEA and GAP analyses.
• Drive the technical execution of assigned projects, supporting process development, scale-up, technology transfer and manufacturing activities.
• Build strong scientific partnerships with clients, provide technical expertise and supporting process-related decisions throughout the project lifecycle.
• Lead technical investigations, risk assessments and process optimization to ensure robust and compliant manufacturing processes.
• Collaborate with Manufacturing, MSAT, Quality, Engineering and other cross-functional teams to ensure successful project execution.
• Present scientific data, project progress and technical recommendations to internal stakeholders and external clients.
• Support client meetings, audits and regulatory inspections as the process technical expert.
• Stay current with emerging technologies and scientific literature to drive innovation and continuous improvement.

Conoscenze

GMP knowledge

English proficiency

Analytical skills

Multi-project management

Formazione

Bachelor's/Master's in Pharmacy or related field

Strumenti

FMEA

GAP analyses

Technical documentation

Descrizione del lavoro

Thermo Fisher Scientific in Monza, Italy, is seeking a Manufacturing Process Scientist to join the PDS team. You will help design, develop and optimize sterile manufacturing processes for clinical and small-scale commercial products, and lead process transfer to cGMP manufacturing suites at Monza.

The role emphasizes scientific leadership, collaboration with cross-functional teams, and close client partnership to deliver robust, compliant manufacturing solutions and ongoing process improvements.