col-wideJob Description:
Application 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.
LNP process development.
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.
Qualifications
Master's Degree in Life Sciences Chemical, Biological or Process Engineering with proven experience in the Biopharmaceutical industry, preferably in a PD role; or PhD in Biochemistry/Chemistry/Chemical Engineering/ Biological Engineering or related scientific subject areas with +2 years of relevant post-doctoral or industrial experience.
Requirements
Knowledge 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 desirable
Expertise 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.
Experience applying U/HPLC, FPLC, CGE, Ribogreen assay and DLS.
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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