Senior Scientist, mRNA Downstream Process Development

Catalent Pharma Solutions; Alabama; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

401(k) match

Medical/dental/vision benefits

Tuition reimbursement

Job summary

Catalent Biologics in Madison, WI seeks a Senior Scientist for Downstream Process Development focused on mRNA. Lead IVT, purification, and analytical characterization, while collaborating with analytical teams to ensure robust process validation and lifecycle readiness.

The role involves designing experiments, supporting tech transfer to GMP sites, and building scalable mRNA processes with QbD principles in a cGMP environment.

Qualifications

• Bachelor's degree with 8–15 years related experience
• Master's degree with 5–10 years related experience
• Doctorate with 2–4 years related experience
• Viral clearance validation, process scale up, tech transfer experience
• cGMP environment experience
• GDP, aseptic technique experience
• Experience mentoring junior staff regarding laboratory procedures and scientific projects

Responsibilities

• 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 and defend it through late phase / commercial readiness
• Apply QbD principles and statistical tools for process characterization and PPQ readiness
• Collaborate with analytical teams for method development and validation of mRNA drug substance
• Participate in tech transfer activities to GMP manufacturing sites for mRNA and protein programs
• Process scale chromatography and filtration experience
• Support downstream process development for monoclonal antibodies and other protein modalities

Skills

mRNA process development

IVT & purification

DOE (Design of Experiments)

cGMP compliance

tech transfer & scale-up

GDP documentation

Education

Bachelor's degree in STEM

Master's degree in STEM

Doctorate in STEM

Tools

Chromatography systems

TFF/Filtration

Analytical characterization

Job description

Catalent Biologics in Madison, WI seeks a Senior Scientist for Downstream Process Development focused on mRNA. Lead IVT, purification, and analytical characterization, while collaborating with analytical teams to ensure robust process validation and lifecycle readiness.

The role involves designing experiments, supporting tech transfer to GMP sites, and building scalable mRNA processes with QbD principles in a cGMP environment.