MSAT Scientist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science. Whether our customers are accelerating life sciences research, solving analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team delivers an outstanding combination of innovative technologies.

ThermoFisher mRNA unit in Monza is looking for a MSAT Scientist role!

What will you do?

- As a member of the Manufacturing Science & Technology Team, the resource will lead the successful transfer, scale up, supervision and optimization of bioprocesses. You are regarded as a senior expert in process science and manufacturing aspects. In this role, you significantly contribute to the development of the MSAT toolbox and share the manufacturing responsibility as a long-term process owner.

- Leading multi-functional teams as a process expert tasked with technology transfers (process design and up-scaling) and timely process implementation at manufacturing scale. This includes the whole lifecycle of assigned projects from planning over coordination, implementation, control and project completion aligned with project management goals. Responsible for execution of GMP risk analysis for the manufacturing processes.

- Act as the interface between the process donor (customer, process development) and operations. Responsible to ensure process scalability and manufacturability.

- Work with Project Manager and Core Team to lead the Technology Transfer from Process Development, other sites and/or Client to Clinical and Commercial Manufacturing, ensuring effective information flow, timeline execution, issue resolution and documentation in accordance with governing tech transfer quality system requirements while demonstrating robust risk management practices.

- Writing of Technical documents such as Process GAP Assessment, Technology Transfer Protocol and Sampling Plans, Technical Reports, FMEA, Risk Assessments, VMP and other documents for PPQ campaign and product commercialization.

- Provide technical and scientific support to any manufacturing process related events such as manufacturing deviations, technical solving, change control and for continuous improvement of process performance.

- Contributing to the development and implementation of standardized MSAT procedures and processes

- Supervising tasks around MSAT initiatives or leading major task forces or troubleshooting teams.

- Performing process specific trainings for production staff.

Education/ Experience

- MS in the life sciences, engineering, or equivalent technical field required with preferred 2+ years of experience in MSAT roles.

Knowledge, Skills, Abilities

- Progressed experience in main Upstream (Media Preparation and Enzymatic reactions in Bioreactors) and in Downstream steps (TFF, Chromatography, Encapsulation, Clarifications/Filtrations).

- Knowledge of steel reactors, tanks at small and/or high scale, with extensive experience in managing industrial equipment, including CIP (Cleaning in Place) and SIP (Sterilization in Place) systems. Expertise in handling sterile transfer lines, implementing sterile strategies for sampling, and other related processes.

- Experience in process design, technology transfer scaling-up, and process optimization, with a focus on process design or improvement of industrial facilities, working closely with engineers.

- Expertise in managing sterile processes and defining sterile strategies for media fill and sterile validation.

- Expertise in sterile filtration and filter validation is a plus.

- Proven manufacturing technical skills and experience in Nucleic Acids, Biologics, or vaccine production.

- cGMP knowledge and process engineering experience.

- A sound understanding of scale-up principles, process validation, and regulatory strategies.

- Proven problem-solving skills in complex and dynamic environments.

Thermo Fisher Scientific is an Equal Opportunity Employer.

Join us, and be part of our Company