Adherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeThermo Fisher Scientific Inc. is the world leader in serving science, with an 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, growing productivity in their laboratories, improving patient health through diagnostics or developing and manufacturing life-changing therapies, we are here to support them. Our global team delivers an unrivalled 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.Your Future TeamThe Scientist joining the team will work within the mRNA Process & Analytical Method Development Group, developing and optimizing methods and transferring them to cGMP and QC groups. The RNA Process and Analytical Development team is a brilliant team of Scientists focused on RNA and LNP technologies.Key responsibilities will include hands-on laboratory tasks, mRNA / LNP process characterization and development for new products, process improvement, and document drafting.ResponsibilitiesApplication of TFF for RNA and LNP downstream.Conduct feasibility assessments, technical consultations, training, and bench trials.Develop robust and scalable downstream processes at the laboratory scale to purify nucleic acids and LNP with liquid chromatography / TFF using DOE-based approaches.Scale up / scale down testing plans and data review, sizing, compatibility, and solving technical issues.Support technology transfer to the cGMP manufacturing and quality control (QC) groups for clinical material production / analysis.Perform routine bench work under limited supervision, prioritize responsibilities effectively, and complete timely assignments.Maintaining domain expertise in new technologies and scientific literature to drive innovation.Train junior scientists as needed.QualificationsRequirementsKnowledge of main purification techniques used for drug manufacturing.Experience in process development for therapeutics with standard downstream purification techniques, including depth filtration, FPLC and TFF.Familiarity with the process of developing mRNA products would be a plus.Experience with GLP and GMP compliance and 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 presenting the work clearly among the team.Ability to multi-task and prioritize to meet deadlines.Ability to respond quickly to evolving priorities.A self-starter and a great teammate.Proficient English and excellent social skills.Highly desirableExpertise in upstream processing, including experience with bioreactors at small, intermediate, and large scales; development of scale-up and scale-down models; and bio reactions optimization.Technical expertise in mRNA synthesis by enzymatic method development.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.
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