Senior Scientist - Downstream Process Development, mRNA

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.  The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA.  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:

• Develop and execute laboratory work plans/schedules independently, using customer
  milestones/and division/site performance standards and metrics. Develop and review statement of work and ensure project stays within scope.
• Author and may approve technical documents such as protocols, test methods, test reports,
  certificates of analysis, and operating procedures
• Review technical documents for accuracy, thoroughness, and regulatory compliance
• Train, coach, or mentor others on technical, personal development or business issues
• Participate in client meetings offering technical support and leading the project
• Research and develop existing and new technologies/process improvements
• Manage client projects independently
• Build and maintain vendor relationships
• Act as the technical lead for client development projects, communicates project status
  internally and externally, and effectively provides technical explanation/rationalization
• Critically analyze complex data; interpret and integrate experimental results with project
  objectives
• Write complex procedural SOPs, batch production records, and reports
• Accurately review batch records and other data, ensuring consistency
• Execute purification experiments including automated chromatography (AKTA platform),
  filtration, clarification, column packing, and tangential flow filtration independently
• Knowledge of protein purification and analysis with an in-depth understanding of all modes of chromatography
• Knowledge of scale up principles with respect to purification and filtration
• Adhere to good documentation practices
• Experience with quality control and quality control tracking systems including change control and deviations
• Update group members on background and status of client projects by giving oral updates or internal presentations
• Maintain project timelines
• Troubleshoot and problem solve to initiate and execute/monitor corrective actions 
• 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 2–4 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