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.  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 lifecycle management Establish and maintain SOPs for mRNA synthesis and purification to ensure reproducibility and compliance Collaborate with analytical teams for method development and validation of mRNA drug substance. 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 modalities preferred.   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 chromatography workstations and 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 staff regarding laboratory 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 2–4 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 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! 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. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice