Manufacturing Process
1 settimana fa
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.
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 challenges related to Pharma Clinical Manufacturing.
As a Scientist, you will work within the MPT Team and contribute to the definition, development, improvement, and transfer of sterile products to cGMP PDS suites.
Key Responsibilities:
- Draft the manufacturing process chart in accordance with the product quality target product profile, product knowledge, and development data.
- Write clear and professional protocols to support timely project completion.
- Craft and develop robust and scalable manufacturing processes.
- 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.
- Analyze, interpret, and present results to project teams, and write technical reports.
- Maintain domain expertise in new technologies and scientific literature 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 the 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 such as work instructions, study protocols and reports, FMEA, and GAP Analysis.
- 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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