Senior Scientist - Downstream Process Development, mRNA

About 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 mor