Scientist - Process Development, Upstream

Scientist – Process Development, Upstream     Catalent is seeking a   Scientist, Process Development – Upstream   to join our   Late-Phase/Process Characterization Upstream Development team   supporting biologics programs as they advance toward validation and commercial manufacturing.   This role focuses on the design and execution of process characterization and optimization studies using scale-down models and statistical approaches to support process understanding,   validation   readiness, and regulatory submissions. The successful candidate will combine strong laboratory   expertise , scientific rigor, data analysis, and technical writing skills to deliver high-quality development solutions for client programs.   About Catalent Madison   Catalent's Madison, Wisconsin facility is   a state-of-the-art   biologics   development and manufacturing site supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail, the 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance manufacturing, and biopharmaceutical process development.   The site is home to Catalent's proprietary   GPEx ® and   GPEx ® Lightning technologies, enabling the generation of high-producing mammalian cell lines for biologic therapies. With production capabilities ranging from 50L to 4,000L and a recent $45 million expansion, the Madison campus continues to play a critical role in Catalent's global   biologics   network while supporting Wisconsin's growing life sciences industry.   Location:   100% Onsite at our facility in Madison, Wisconsin   Shift:   Monday – Friday, First Shift    Key Responsibilities   Design and execute upstream process characterization, optimization, and validation support studies for mammalian cell culture processes.   Perform mammalian cell culture activities including cell bank thawing, seed train expansion, small-scale bioreactor operations, and analytical testing.   Leverage statistical tools and Design of Experiments (DOE) methodologies to evaluate process performance and   establish   process understanding.   Utilize scale-down models and automated bioreactor systems to support process characterization and commercialization activities.   Analyze experimental data and prepare technical conclusions to support project decision-making and regulatory filings.   Author and review technical documents including study protocols, reports, SOPs, and regulatory-supporting documentation.   Collaborate closely with multidisciplinary teams supporting technology transfer, validation, manufacturing, and client programs.   Contribute to continuous improvement initiatives and support training and mentoring activities within the department.   Other responsibilities as needed.

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.

Experience with process characterization, process validation, or commercial manufacturing support activities.   Experience   utilizing   Design of Experiments (DOE) and statistical analysis tools.   Experience with