Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We are seeking a highly motivated Intern candidate for the role of TT Scientist in the mRNA Process and Analytical Development team in Monza (Italy).

YOUR FUTURE TEAM:

The TT Intern joining the team will work within the mRNA Process & Analytical Method Development Group and chip in to the development of process and analytical methods, improvements, and transfer of RNA products to the GMP group. The RNA Process and Analytical Development team is a hard-working and upbeat team of Scientists focused on RNA and LNP technologies.

Key responsibilities will include TT of RNA synthesis/ formulation processes and document drafting.

ABOUT THIS OPPORTUNITY:

We are seeking an Intern to support the transfer of development processes from customers to the RNA/LNP Process Development (PD) laboratory and subsequently from the PD lab to GMP manufacturing. This role involves collaboration with the RNA/LNP Process Development team and the MSAT team. The ability to multi-task and adapt to shifting priorities is critical.

• KEY JOB RESPONSIBILITIES

• Provide technical transfer support for mRNA/LNP projects transitioning from process development to manufacturing.

• Conduct facility gap assessments, including raw material evaluations.

• Assist in the authoring of technical protocols and reports.

• Complete tasks necessary to generate materials (non-GMP) for scale-up, investigations, customer requests, and technical transfers. This includes, but is not limited to, assigning part numbers for new raw materials, creating labels, preparing Safety Data Sheets (SDS), supporting providers codification, generating bills of materials, procuring materials, and creating sampling plans.

• Support technical investigations and troubleshooting within the mRNA/LNP manufacturing process.

• Help establish credibility and positive relationships with collaborators and functional groups.

• Perform process monitoring and data analysis, prepare reports, and deliver presentations.

• Assess customer inquiries and development/scale-up production requests, including batch scaling proposals.

• Generate Bills of Materials.

• KEY REQUIREMENTS

• MSc with experience in life sciences, biotechnology, or engineering.

• Strong background in biochemistry or molecular biology is required; direct experience with RNA/DNA manipulation and lipid nanoparticle formulation is highly preferred.

• Excellent technical writing skills.

• Proficiency in English is crucial; proficiency in Italian is required.

• Knowledge of Good Manufacturing Practice (GMP).

• Strong customer focus, dedicated to providing high-quality products and services that meet all expectations.

• Meticulous and independently motivated.

• Ability to draft clear documentation for manufacturing, procurement, and quality compliance efficiently.

• Support the interface between Supply Chain (SC), Process Development, Quality Control/Analytical Development (QC/AD), Environmental Health and Safety (EHS), and Project Management (PM) to ensure the successful technical transfer of PD processes into manufacturing.

• Assist in the development and revision of Process Development Master Batch Records (MBRs) as needed to ensure documentation reflects current operations, meets industry standards, and fulfills customer expectations.

• Provide support in the preparation of technical transfer documentation, process transfer-related deviations, and campaign summary documentation.

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!