Scientist - Process Development, Upstream

**Scientist – Process Development, Upstream**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. Successful candidates may be assigned to different upstream development teams based on business needs and experience. Opportunities include support of early-stage process development programs as well as late-phase process characterization, validation, and commercial manufacturing initiatives. The successful candidate will combine strong laboratory expertise with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and 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 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. - Other responsibilities as needed. **Required Qualifications** - 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 biolog…