Senior Scientist - Downstream Process Development, mRNA

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

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.

Requirements

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
Experience writing standard operating procedures, batch records, and reports
Experience mentoring junior staff regarding laboratory procedures and scientific project

Responsibilities

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.

Benefits

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!
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference. personal initiative. dynamic pace. meaningful work.