Manufacturing Process Scientist

Work Schedule

Environmental Conditions

Job Description

How will you make an impact

Thermo Fisher Scientific Inc. is the world leader in serving science with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier cleaner and safer. Whether our customers are accelerating life sciences research solving complex analytical challenges improving laboratory efficiency advancing patient health through diagnostics or developing and manufacturing life-changing therapies we are here to support them.

We are seeking a highly motivated Manufacturing Process Scientist to join the Pharmaceutical Development Services (PDS) team in Monza Italy.

The Pharmaceutical Development Services (PDS) division specializes in clinical and small-scale commercial contract manufacturing of sterile injectable drug products including liquid and lyophilized formulations.

You will join the Process Manufacturing Sciences team where scientists design develop and optimize manufacturing processes for innovative therapies working in close partnership with clients and cross-functional teams. This role offers the opportunity to contribute to the successful delivery of life-changing medicines while developing your scientific expertise in a dynamic and collaborative environment.

What will you do

As a Manufacturing Process Scientist you will support the development optimization and technology transfer of sterile manufacturing processes into the cGMP manufacturing suites at the Monza site.

As the Process Subject Matter Expert (SME) for assigned projects you will provide scientific leadership throughout the project lifecycle partnering with clients and cross-functional teams to develop robust scalable and compliant manufacturing processes for clinical and commercial products.

Your responsibilities will include:

• 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.

Qualifications

Minimum Qualifications

• Bachelors or Masters 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 is a must.
• 2-3 years of experience with liquid suspension and/or lyophilized drug products is also a must.
• Good knowledge of GMP requirements; experience with 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 is a must.
• Excellent written and verbal communication skills in English.

Preferred Competencies

• Strong scientific mindset with excellent analytical and problem-solving skills.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Excellent communication and presentation skills with the ability to interact effectively with clients and cross-functional teams.
• High attention to detail and commitment to quality.
• Curiosity accountability and a continuous learning mindset.
• Ability to work both independently and collaboratively within multidisciplinary teams.

Join us!

At Thermo Fisher Scientific each one of our more than 100000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier cleaner and safer.