Scientist - Process Development, Upstream

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

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. 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.

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.

Nice To Haves

Experience with process characterization, process validation, or commercial manufacturing support activities.
Experience utilizing Design of Experiments (DOE) and statistical analysis tools.
Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar platforms.
Experience supporting regulatory submissions or generation of regulatory-supporting technical documentation.
Experience in a GMP-regulated biotechnology, pharmaceutical, or CDMO environment.
Previous client-facing experience.

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.