Key Responsibilities:
As Scientist, you will work chip in to the definition, development, improvement, and transfer of sterile products to cGMP PDS suites of Monza site. You will draft the manufacturing process chart in accordance with the product quality target profile, product knowledge and development data as well as write clear and professional protocol to support timely project completion. As SME of process you will ask to support scale-up of lab-scale processes and technology transfer to the cGMP manufacturing for clinical and commercial batches. Discussing the progress of activities and propose technical solutions with internal and external partners is crucial.

Should also be able to analyze, interpret, and present results to project teams, and write technical reports.

Qualifications:
B.S or M.S. in Medicinal Chemistry/Chemistry/Chemical Engineering/Biotechnology or related scientific subject areas with meaningful expertise 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 achievements.
Maintaining up-to-date in new technologies and scientific literature to drive innovation.

Critical thinking and curiosity.
A self-starter and outstanding 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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