Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office

Job Description

We are seeking a highly motivated candidate for the role of Technology Transfer Scientist in the mRNA/LNP Process and Analytical Development team in Monza (Italy). The position requires expertise in mRNA Upstream (IVT) and Downstream (Chromatography and TFF) and LNP formulation and downstream (TFF) and Filtration.

Your Future Team

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

About This Opportunity
We are seeking for a technology transfer scientist to support the transfer of development processes from customers to the mRNA/LNP Process Development laboratory and subsequently from the PD lab to GMP manufacturing. This role involves collaboration with the mRNA/LNP Process Development team and the MSAT team. The ability to multi-task and adapt to shifting priorities is critical.

Key Job Responsibilities
-Provides front-line SME support for mRNA/LNP projects during the transition of end-to-end technical transfers from process development to manufacturing production.
-Support development and optimization of scalable processes to ensure efficient and reproducible manufacturing outcomes.
-Design and execute process scale-up activities to facilitate the production of non-GMP Drug Substance and Drug Product.
-Conduct facility gap assessments, including GMP grade raw material identification and equipment evaluations.
-Assist in the authoring of Bills of Materials, technical protocols, sampling plan and final report.
-Analyse and rationalize customer requests, providing technical support for supplier codification and material procurement.
-Collaborate with suppliers to ensure the timely and accurate delivery of materials required for production.
-Support technical investigations and troubleshooting efforts within the mRNA/LNP manufacturing process.
-Establish and maintain positive relationships with customers, external collaborators, and internal functional groups.
-Perform process monitoring and data analysis, prepare reports, and deliver presentations to communicate findings and recommendations to stakeholders.
-Assess customer inquiries and development/scale-up production requests, including batch scaling proposals.
-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.

Key Requirements
-PhD or MSc with equivalent experience in chemical or process engineering or biotechnology, with relevant industrial experience.
-Strong background in biochemistry or molecular biology is required; direct experience with RNA/DNA manipulation and downstream phases including chromatography (AKTA FPLC systems) and TFF.
-Excellent technical writing skills, problem-solving, process and analytical skills
-Proficiency in English is crucial; proficiency in Italian is required.
-Knowledge of Good Manufacturing Practice (GMP) and industrial processes.
-Strong customer focus, dedicated to providing high-quality products and services that meet all expectations.
-Meticulous and independently motivated.
-Effective communication and interpersonal skills.
-Ability to work collaboratively in a fast-paced, dynamic environment.