MSAT Scientist

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with 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 analytical challenges, growing productivity 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, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

• Provide technical support to PD scientists, and associates for process validation and commercial stage products including being responsible for the design and execution of studies, investigation and data analysis of results, and writing/review of technical protocols and reports.
• Work with Project Manager to Lead 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.
• Work closely with the clients and internal Manufacturing, Process Development, Quality Control, Quality Assurance, Operations, and Project Management to ensure standard methodologies are followed.
• Write and/or review of technical reports and/or any source documentation and reports required (such as Trials and Engineering Protocols/reports and working instructions).
• Perform detailed technical review of internal and external project documents (e.g., tech transfer documents, development/process characterization, process validation plans, production/test records, summary reports).
• Provide technical and scientific support any manufacturing process related events such as manufacturing deviations, technical solving, change control and optimizations
• Ensure robust strategies and approaches for facility fit and process gap analyses and risk assessments in support of process definition and improvement.
• Help to define and implement the MS&T procedures, systems, and practices for new product introduction, process validation, and continuous process verification in accordance with cGMP and ICH guidelines.
• Provide on-floor technical support for manufacturing processing, as needed.

• B.S in the life sciences, engineering, or equivalent technical field required; 4+ years of experience, or MS and 4+ years of relevant experience or a PhD and 2+ years of relevant experience, preferred

• Demonstrated manufacturing technical support experience in Nucleic Acids, Biologics, or vaccine production
• cGMP knowledge and process engineering experience
• A sound understanding of RNA production and analytics, scale-up principles, process validation, and regulatory strategies.