Associate Scientist - Downstream Process Development

About the role

Work Schedule: Monday-Friday100% on-site Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem. The Product Development network supports development of biologic modalities (mAbs, novel protein modalities, mRNA, exosomes, enzymes, viral proteins) from initial early phase through late-stage projects to PPQ and launch. The Development team designs and conducts process, analytical, and formulation work. For scale-up, the Upstream (US) based teams in Manufacturing Science and Technology (MS&T) support tech transfer for Downstream (DS) and fill finish (Catalent or client developed processes). The Downstream Process Development team is responsible for the development and implementation of downstream processing methodologies and analytical procedures that can be easily transferred to the cGMP Manufacturing Team. The process characterization function within the Downstream Process Development group will be responsible for the characterization of previously developed or transferred processes heading towards commercial manufacturing.

Responsibilities

• Support Downstream Process Development laboratory operations by performing scientific and technical activities accurately, safely, and in accordance with established procedures.
• Develop, maintain, and troubleshoot capacity modeling workflows and software used for Process Development planning and resource forecasting.
• Review and reconcile capacity models against signed client contracts to ensure planning data remains accurate and current.
• Coordinate material procurement activities, including obtaining vendor quotes, creating part numbers, tracking deliveries, and resolving material availability issues.
• Partner with Process Development Scientists and Procurement to create and manage pilot work orders and ensure timely availability of materials for development activities.
• Participate in production planning meetings, providing updates on schedules, material status, capacity requirements, and potential risks.
• Perform laboratory support functions, including solution preparation, equipment maintenance, inventory management, dishwashing, autoclaving, and laboratory housekeeping.
• Maintain and promote 5S and continuous improvement initiatives through audits, corrective actions, workspace organization, and process enhancement projects.
• Design and execute downstream purification experiments, including chromatography (AKTA), filtration, clarification, column packing, and tangential flow filtration, while analyzing experimental data and documenting results.
• Author and review technical documents, protocols, reports, and laboratory records while ensuring compliance with Good Documentation Practices (GDP) and quality standards.
• Other duties as assigned

Requirements

Bachelor's degree in a STEM discipline with a minimum of 1 years of related experience

Benefits

• Competitive medical benefits and 401K
• 152 hours of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Potential for career growth on an expanding team
• Abundance of cross-functional exposure to other areas within the organization
• Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
• Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
• Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
• personal initiative. dynamic pace. meaningful work.

Schedule

Monday-Friday 100% on-site