Scientist - Analytical Development

Scientist – Analytical Development   Catalent is seeking a Scientist –  Analytical Development   to join our cell therapy manufacturing facility in Madison, Wisconsin.   The Analytical Development team is responsible for evaluating client analytical methods and optimizing/developing methods that support cell line, upstream, and downstream process development. The team applies analytical quality by design ( AQbD ) principles to characterize biologics, establish product quality attributes, and support technology transfer, IND-enabling studies, and regulatory submissions. This group plays a critical role in ensuring high-quality analytical methods and data that support the successful development of innovative biologic therapies for Catalent clients and their patients.   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   Analytical Testing & Characterization: Independently execute analytical testing of proteins, monoclonal antibodies ( mAbs ), mRNA products, and other biological macromolecules using a broad range of biochemical, biophysical, and molecular biology techniques.   Method Development & Optimization: Develop, optimize , qualify, and support transfer of analytical methods while applying Analytical Quality by Design ( AQbD ) and Design of Experiments (DoE) principles to generate robust and phase-appropriate analytical strategies.   Analytical Technologies: Perform and troubleshoot analytical techniques including ELISA, Western Blot, SDS-PAGE, Agarose Gel Electrophoresis, HPLC/UHPLC, Capillary Electrophoresis (CE), cIEF , LC-MS, qPCR, Sanger Sequencing, and product binding or potency assays.   Data Analysis & Scientific Interpretation: Analyze experimental data, identify trends, draw scientific conclusions, and communicate results clearly to project teams while ensuring data integrity and technical accuracy.   Documentation & GMP Compliance: Author, review, and maintain technical documents, laboratory records, SOPs, protocols, and reports in compliance with GMP requirements and Good Documentation Practices (GDP).   Cross-Functional Collaboration & Client Support: Partner with Process Development, Cell Line Development, Quality, Manufacturing, and Project Management teams while supporting client-facing discussions and project milestones.   Laboratory Operations & Continuous Improvement: Support laboratory organization, equipment maintenance, inventory management, troubleshooting activities, and continuous improvement initiatives that enhance efficiency and quality.   Other responsibilities as needed.   Required Qualifications   Associate degree in a STEM discipline with a minimum 10 years of relevant laboratory experience, Bachelor's degree in a STEM discipline with a minimum 6 years of relevant laboratory experience, Master's degree in a STEM discipline with a minimum  3 years of relevant laboratory experience, or PhD in a STEM discipline with relevant academic, industry, or postdoctoral experience.   Hands-on experience performing analytical characterization of proteins, biologics, or other biological macromolecules in a laboratory environment.   Experience generating, analyzing, and interpreting scientific data to support development programs and technical decision-making.   Strong working knowledge of laboratory documentation practices, data integrity requirements, and technical report writing.   Ability to independently plan, execute, troubleshoot, and prioritize laboratory experiments in a fast-paced environment.   Strong verbal and written communication skills with the ability to collaborate effectively across multidisciplinary teams.   Proficiency with Microsoft Office applications and electronic laboratory documentation systems.   Preferred Qualifications   Experience with analytical techniques such as ELISA, Western Blot, SDS-PAGE, Agarose Gel Electrophoresis, HPLC/UHPLC, Capillary Electrophoresis (CE), cIEF , Product Binding and Potency Assays, LC-MS, qPCR, and Sanger Sequencing.   Experience supporting biologics development programs involving recombinant proteins, monoclonal antibodies ( mAbs ), mRNA therapeutics, or related modalities.   Experience applying AQbD and DoE principles to analytical method development, optimization, or lifecycle management activities.   Experience working in a GMP-regulated biotechnology, pharmaceutical, biopharmaceutical, CRO, or CDMO environment.   Experience authoring or reviewing SOPs, protocols, validation documentation, technical reports, and regulatory-supporting documentation.   Experience mentoring, training, or onboarding junior scientists and laboratory personnel.   Previous client-facing experience supporting technical project updates, scientific discussions, or development program meetings.   Why you should join Catalent     Opportunity to play a key role in driving growth within a global CDMO leader.    Competitive compensation package, including incentive opportunity.    Day-one medical, dental, and vision coverage.    401(k) with company matc