Senior Scientist - Downstream Process Development, mRNA

Senior Scientist – Downstream Process Development, mRNA

Position Summary:

Catalent Biologics, a fast‑growing business within Catalent Pharma Solutions, is focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. This role 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.

Work Schedule:

M‑F 8am‑5pm, 100% on‑site.

• Design and optimize in‑vitro transcription (IVT) reactions, enzymatic processing, and purification workflows.
• Develop scale‑down models and execute DOE studies for process characterization and development.
• Author process development reports, validation protocols, and risk assessments (FMEA, CPP identification).
• Define a control strategy for mRNA drug substance (CPPs, CQAs, IPCs, acceptance criteria, sampling plans) and defend 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, including authoring or reviewing method validation/qualification strategies.
• Participate in tech transfer activities to GMP manufacturing sites for both mRNA and protein programs.
• Operate, maintain, and troubleshoot chromatography workstations and process skids, preferably in an industrial setting.
• Process scale chromatography and filtration (chromatography, tangential flow, normal flow) experience.
• Process scale‑up and technology transfer, viral clearance validation, and cGMP experience.
• Apply Good Documentation Practices (GDP) and aseptic technique.
• Write standard operating procedures, batch records, and reports.
• Mentor junior staff regarding laboratory procedures and scientific projects.

• Bachelor’s degree in a STEM discipline with 8‑15 years of related experience, ORMaster’s degree with 5‑10 years of related experience, OR Doctorate with 2‑4 years of 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.
• Experience working in a cGMP environment and 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.

• Support downstream process development for monoclonal antibodies and other protein modalities.
• Ability to author or review method validation/qualification strategy and understand suitability for intended use (development vs GMP release).

• Defined career path and annual performance review.
• Diverse, inclusive culture with a positive working environment.
• 152 hours of PTO + 8 paid holidays.
• Generous 401(k) match.
• Medical, dental, and vision benefits effective day one.
• Tuition reimbursement.

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, please contact Disabili and include the job number, title, and location.