Scientist I, Process and Analytical Development (IVT, CGE, HPLC, FPLC, TFF)

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SCIENTIST I, PROCESS AND ANALYTICAL DEVELOPMENT

Job Description

• We are seeking two highly motivated candidates for the role of Junior Scientists in the mRNA Process, Analytical and LNP Formulation Development team in Monza (Italy).

• The candidates shall have strong ability in upstream/downstream process development and are expected to work in a fast-paced environment with high self-motivation.

• The Junior Scientists will work within the Process & Analytical Method Development Group and will contribute to successful process & analytical methods' development, improvements, and transfer of mRNA products to GMP and QC groups.

• Key responsibilities will include hands-on laboratory development, mRNA process characterization & development for new products, process improvements, technical document drafting and updates.

Responsibilities:

• Develop and implement scalable mRNA purification strategies, to generate highly pure material.

• Design, develop, and implement workflows for mRNA production.

• Uses a data-driven approach to progress development deliverables.

• Develop robust and scalable downstream processes at the laboratory scale for the purification of nucleic acids with tangential flow filtration and liquid chromatography.

• Perform troubleshooting process performance issues.

• Support scale-up of upstream/downstream processes and technology transfer to the cGMP manufacturing and quality control groups for clinical material production.

• Perform routine bench work under limited supervision, effectively prioritize responsibilities and complete assignments in a timely manner.

• Able to analyze, interpret, and present results to project teams and write technical reports.

• Maintaining domain expertise in new technologies and scientific literature to constantly drive innovation.

Qualifications:

• B.S. with 4+ years of relevant experience in the industry or M.S. with 3+ years of relevant experience in the industry.

• Training in Biochemistry/Chemistry/Chemical engineering/Molecular biology or related scientific subject areas with proven experience.

Requirements:

• Demonstrated experience with standard analytical equipment (plate reader, nanodrop, spectrophotometer, PCR, protein and nucleic acid electrophoresis) and knowledge of molecular biology, biochemistry, and biophysics protocols is required.

• Strong technical expertise in two or more of the following: in vitro transcription (IVT) synthesis, molecular cloning, capillary gel electrophoresis (CGE) high-performance liquid chromatography (HPLC), fast protein liquid chromatography (FPLC), and tangential flow filtration (TFF).

• Experience in upstream processing, including use of bioreactors at small, intermediate, and large scales; familiarity with the process development of mRNA products would be a plus.

• Experience writing content for technical 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.

• A self-starter and great teammate.

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