Scientist I, Process Development

06 ago - Monza
Thermo Fisher Scientific

**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting **Thermo Fisher Scientific Inc. is the world leader in serving science, with an 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, increasing productivity in their laboratories, improving patient health through diagnostics or developing and manufacturing life-changing therapies, we are here to support them. Our global team delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.**:
**Your Future Team**:
**The Scientist joining the team will work within the mRNA Process & Analytical Method Development Group and contribute to the development of process and analytical methods, improvements, and transfer of mRNA products to cGMP and QC groups. The RNA Process and Analytical Development team is a brilliant and energetic team of Scientists focused on RNA and LNP technologies.**:
**Key responsibilities will include hands-on laboratory development, mRNA formulation characterization & development for new products, process improvements, and document drafting.**:
**Responsibilities**: - ** Design and optimization of lipid nanoparticle (LNP) for the encapsulation of nucleic acids**:



- ** Develop robust and scalable LNP formulation processes at the laboratory scale for the encapsulation of nucleic acids using DoE-based approaches.**: - ** LNP process development scale-up**: - ** Application of tangential flow filtration process for LNP downstream**: - ** Application of preparative FPLC/HPLC purifications**: - ** Design, execute, and troubleshooting experiments to optimize assay performance and provide clear and concise project status updates to internal and external stakeholders.**: - ** Support scale-up of upstream/downstream processes and technology transfer to the cGMP manufacturing and quality control (QC) groups for clinical material production/analysis.**: - ** Perform routine bench work under limited supervision, prioritize responsibilities effectively, and complete timely assignments.**: - ** Discuss the progress of activities and propose technical solutions with internal and external stakeholders.**: - ** Maintaining domain expertise in new technologies and scientific literature to constantly driving innovation.**:
**Qualifications**:
**Requirements**: - ** Familiarity with the LNP process development for nucleic acid products: microfluidic, T, X, jet impingement mixing systems.**:



- ** Experience with LNP conjugation, LNP functionalization, and hybrid nanoparticles**: - ** Experience in process development for therapeutics with standard downstream purification techniques, including FPLC and TFF.**: - ** Experience with development and characterization of mRNA-LNPs (DLS, fluorescence-based assays - Ribogreen, TEM, CGE)**: - ** Experience writing content for documentation, including SOPs, work instructions, technical protocols and reports, and technical presentations.**: - ** A high level of commitment and a track record of quality work, with attention to detail.**: - ** Capable of communicating the work clearly among the team.**: - ** Ability to multi-task and prioritize to meet important deadlines.**: - ** Ability to respond quickly to constantly evolving priorities.**: - ** A self-starter and a great teammate.**: - ** Fluent English and Italian and excellent communication skills**:
**Highly desirable**: - ** Technical expertise in mRNA synthesis by enzymatic method development will be a plus.**: - ** Expertise in upstream processing, including experience with bioreactors at small, intermediate, and large scales; development of scale-up and scale-down models and bio reactions optimization.**:
**Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, creed, religion, colour, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age, or disability status.**:
Join us!

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