Senior Scientist - Downstream Process Development, mRNA

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

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 andoptimizeIVT reactions, enzymatic processing, andpurificationworkflows

• Develop scale-down models and execute DOE studies for process characterization andprocess development
• Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification)
• Definea 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 lifecycle management
• Establish andmaintainSOPs for mRNA synthesisandpurification to ensure reproducibility and compliance
• Collaborate with analytical teams for method development and validation of mRNA drugsubstance.Experience authoring or reviewing method validation/qualification strategy and understanding suitability for intended use (development vs GMP release)preferred
• Ability to support downstream process development for monoclonal antibodies and other protein modalitiespreferred.
• Participate in tech transfer activities to GMP manufacturing sites for both mRNA and protein programs.
• Process scale chromatography and filtration (chromatography, tangential flow, normal flow) experience
• Operating,maintaining, and troubleshooting chromatographyworkstationsand process skids preferably in an industrial setting
• Process scale up and 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 staffregardinglaboratory procedures and scientific projects
• Other duties as assigned.

The Candidate:

• Bachelor's degree in a STEM discipline and 8-15 years related experience, OR
• Master's degree in a STEM discipline and 5-10 years related experience, OR
• Doctorate Degree in a STEM discipline and 2 6 years related experience
• Process scale chromatography and filtration (viral, chromatography, tangential flow,
  normal flow) experience
• Operating, maintaining, and troubleshooting chromatography workstations and process
  skids preferably in an industrial setting
• Viral clearance validation, process scale up, and 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 regarding laboratory procedures and scientific project

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement- Let us help you finish your degree or start a new degree!