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 complex analytical challenges, increasing 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 global team delivers an unrivaled 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.
The Scientist will join the mRNA Process & Analytical Method Development Group and will contribute to the process & analytical methods development, improvements, and transfer of mRNA products to GMP and QC groups. Key responsibilities will include hands-on laboratory mRNA process characterization & development, process improvements, development in the context of mRNA-lipid nanoparticle (LNP) drug products, and technical document drafting.
**Responsibilities**:
- Design, develop, and implement workflows for high-throughput mRNA production.
- Use a data-driven approach to progress development deliverables.
- Process development, improvement, and troubleshooting for LNP/mRNA production at various scales.
- Characterize LNP formulations and components using: Dynamic Light Scattering (DLS), Ribogreen, and high-performance liquid chromatography (HPLC).
- Develop novel assays or in-depth studies of specific LNP attributes as required.
- Screen final formulation buffers and excipients to increase the long-term stability of LNPs.
- Characterize and evaluate LNP formulations to support internal and customer programs.
- Conduct troubleshooting process performance issues.
- Support scale-up of upstream/downstream processes and technology transfer to the cGMP manufacturing and quality control (QC) groups for clinical material production/analysis.
- Perform routine bench work under limited supervision, effectively prioritize responsibilities and complete assignments on time.
- Discuss internally and with customers the progress of the activities proposing technical solutions.
- Ability 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.
- Train junior scientists as needed.
**Qualifications**:
**Requirements**:
- Experience in manufacturing LNPs using Microfluidics, T-mixer, or other inline mixers.
- Experience with tangential flow filtration (TFF) and sterile filtration.
- Proficiency with related LNP/mRNA analytical techniques: plate-based fluorescence assays, high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC/MS), capillary gel electrophoresis (CGE), Dynamic Light Scattering (DLS), zeta potential. There may be additional techniques (PCR, qPCR, UV-Vis spectrophotometry).
- Direct experience in the production and analytical characterization of mRNA lipid nanoparticles as well as the characterization and handling of mRNA products.
- It would be advantageous to have specific experience with the process development of mRNA lipid nanoparticle products.
- Excellent understanding of the mRNA delivery scientific literature.
- Knowledge of design of experiments (DoE) statistical techniques, process modelling, and bioprocess engineering principles.
- Experience with tech transfer to GMP manufacturing preferred.
- Experience writing content for 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.
- Ability to multi-task and prioritize to meet important deadlines.
- Ability to respond quickly to rapidly changing priorities.
- A self-starter and standout colleague.
- Excellent written and spoken English.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration 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.
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