Catalent Biologics
Pharma Solutions
SeniorScientistDownstreamProcessDevelopment,mRNA
“Senior Scientist - Downstream Process Development, mRNA at Catalent Biologics. Skills: mRNA Process Development, Downstream Process Development, Chromatography, Filtration. Design IVT reactions. Optimize enzymatic processing”
What You'll Achieve.
Advance new medicines; Bring products to patients
Industry & Context.
Process optimization; Process characterization; Troubleshooting
100% on-site, Work Schedule: M-F 8am-5pm
What They're Looking For.
Must Have
Bachelor's degree in a STEM discipline and 8-15 years related experience, Master's degree in a STEM discipline and 5-10 years related experience, Doctorate Degree in a STEM discipline and 2–4 years related experience, Process scale chromatography and filtration experience, Operating, maintaining, and troubleshooting chromatography workstations and process skids, Viral clearance validation, Process scale up, Technology transfer, Knowledge and experience working in a cGMP environment, Good documentation practices (GDP), Aseptic technique experience, Experience writing standard operating procedures, batch records, and reports, Experience mentoring junior staff
Nice to Have
Ability to support downstream process development for monoclonal antibodies and other protein modalities, Experience authoring or reviewing method validation/qualification strategy, Understanding suitability for intended use (development vs GMP release)
What You'll Do.
Optimize enzymatic processing
Develop purification workflows
Develop scale-down models
Author process development reports
Author validation protocols
Author risk assessments
Define control strategy
Collaborate with analytical teams
Support downstream process development
Participate in tech transfer
Troubleshoot chromatography workstations
Troubleshoot process skids
How You'll Work.
Team & Collaboration
Collaborate with analytical teams; Work with product team
Process & Methodology
Process scale up, Technology transfer
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