Catalent Biologics
Pharma Solutions
SeniorScientist-DownstreamProcessDevelopment,mRNA
Neural analysis suggests this role is
optimal for Senior candidates.
“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
Full Job Description
**Senior Scientist - Downstream Process Development, mRNA** **Position Summary:** * **Work Schedule: M-F 8am-5pm** * **100% on-site** Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. **Catalent Pharma Solutions in Madison, WI is hiring a Senior Scientist - Downstream Process Development, mRNA.** The Process Development Senior Scientist, mRNA will lead and support the development, optimization, and process characterization of manufacturing processes for mRNA-based therapeutics and vaccines, spanning early-phase clinical through commercial programs. This role requires hands-on expertise in mRNA process development, including in vitro transcription (IVT), purification, and analytical characterization. The scientist will bring deep mRNA technical expertise and demonstrate continuous learning and adaptability, recognizing that supporting multiple modalities, including protein biologics, may be required to meet evolving client and business needs. **The Role:** * Design and optimize IVT reactions, enzymatic processing, and purification workflows * Develop scale-down models and execute DOE studies for process characterization and process development * Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification) * Define a control strategy for mRNA DS (CPPs, CQAs, IPCs, acceptance criteria, sampling plans) and defending it through late phase / commercial readiness * Apply Quality by Design (QbD) principles and statistical tools for process characterization and PPQ readiness * Ensure compliance with FDA, EMA, and ICH guidelines for process validation and li
Applying for this Senior Scientist - Downstream Process Development, mRNA role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Catalent Biologics?
Real rants from real employees. Read before you apply.