Manufacturing Process & Technology Scientist

at  Thermo Fisher Scientific

JOB DESCRIPTION

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, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies.
We are seeking a highly motivated candidate for the role of Manufacturing Process Scientist in the PDS team in Monza (Italy). The position requires expertise in manufacturing and process technology to address various challenge related to the Pharma Clinical Manufacturing.
As Scientist, you will work within the MPT Team and you will contribute to the definition, development, improvement, and transfer of sterile products to cGMP PDS suites.
Key responsibilities will include hands-on manufacturing process characterization & development for new products, process improvements, and document drafting.
Responsibilities:
As Process Scientist you will draft the manufacturing process chart in accordance with the product quality target product profile, product knowledge and development data as well as write clear and professional protocol to support timely project completion.
Craft and develop robust and scalable manufacturing process.
Support scale-up of lab-scale processes and technology transfer to the cGMP manufacturing for clinical material production/analysis.
Discuss the progress of activities and propose technical solutions with internal and external partners.
Should also be able to analyze, interpret, and present results to project teams, and write technical reports.
Maintaining domain expertise in new technologies and scientific literature is essential to constantly drive innovation.
Qualifications:
B.S or M.S. in Medicinal Chemistry/Chemistry/Chemical Engineering/Biotechnology or related scientific subject areas with 3-5 years of meaningful experience in pharma industry.
Requirements:
Proven experience in development and manufacturing of sterile products and lyophilized products
Experience with GLP and GMP compliance and manufacturing preferred.
Experience writing content for technical documentation as work instructions, study protocols and reports, FMEA, GAP Analisys
A high level of dedication and a track record of quality work, with attention to detail.
Capable of presenting the work clearly among the team.
Ability to multi-task and prioritize to meet important deadlines.
Ability to respond quickly to new priorities.
A self-starter and phenomenal teammate.
Excellent written and spoken English.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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