Scientist - Process Development, Upstream

About the role

Catalent is seeking Scientists, Process Development – Upstream to support the development, optimization, characterization, and transfer of mammalian cell culture processes for biologics manufacturing. Scientists in this role may support projects across multiple development stages, including early-phase process development, process characterization, validation readiness, and clinical/commercial manufacturing support.

Responsibilities

• Design and execute upstream process development studies supporting biologics programs from early development through commercial readiness.
• Perform mammalian cell culture activities including cell bank thawing, seed train expansion, bioreactor operations, and analytical testing.
• Support process optimization, process characterization, scale-up, validation readiness, and technology transfer activities using platform methods and statistical tools, including Design of Experiments (DOE).
• Analyze experimental data and communicate results through presentations, technical recommendations, and project updates.
• Maintain GMP-compliant documentation and author or review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation.
• Serve as a technical resource for internal teams and external clients by communicating project progress, presenting results, and supporting project execution.
• Contribute to continuous improvement initiatives, laboratory operations, and the training and mentoring of junior team members.

Requirements

• Bachelor's degree in a STEM discipline with a minimum of 6 years relevant experience, Master's degree with a minimum of 3 years relevant experience, or PhD with relevant academic experience.
• Experience with upstream process development, mammalian cell culture, bioreactor operations, or related biologics development activities.
• Ability to independently design, execute, analyze, and troubleshoot complex experiments in a fast-paced environment.
• Strong understanding of GMP documentation practices, data integrity requirements, and technical writing, including protocols, reports, and SOPs.
• Demonstrated analytical and problem-solving skills with the ability to interpret data, identify process improvements, and recommend technical solutions.
• Proficiency with Microsoft Office applications and laboratory or manufacturing software systems.

Preferred Qualifications

• Experience in upstream biologics process development, process characterization, or process optimization.
• Experience with technology transfer, validation support, scale-up, or commercial manufacturing programs.
• Working knowledge of statistical analysis tools and Design of Experiments (DOE).
• Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar technologies.
• Experience authoring technical reports, protocols, and regulatory-supporting documentation.
• Experience in a GMP-regulated biopharmaceutical, biotechnology, or CDMO environment.
• Previous client-facing experience.