Scientist I, Process Development

Work Schedule

Environmental Conditions

Job Description

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 lifechanging therapies we are here to support them. Our global team delivers an unrivalled combination of innovative technologies purchasing convenience and pharmaceutical services through our industryleading brands including Thermo Scientific Applied Biosystems Invitrogen Fisher Scientific Unity Lab Services Patheon and PPD.

We are seeking a highly motivated candidate for the role of Scientist in the mRNA Process and Analytical Development team in Monza (Italy). The position requires expertise in LNP formulation and the tangential flow filtration (TFF) process for RNA and LNP downstream.

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 handson 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 DoEbased approaches.

• LNP process development scaleup

• 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 scaleup 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

• Masters Degree in Engineering Biotechnology or Biological Chemical with 5 years of relevant experience in the Biopharmaceutical industry preferably in PD role or PhD in Biochemistry/Chemistry/Chemical Engineering/ Biological Engineering or related scientific subject areas with 2 years of relevant postdoctoral or industrial experience.

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 mRNALNPs (DLS fluorescencebased 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 multitask and prioritize to meet important deadlines.

• Ability to respond quickly to constantly evolving priorities.

• A selfstarter 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 scaleup and scaledown 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!