Senior Associate Scientist, Downstream Process Development

Senior Associate Scientist Downstream Process Development

Position Summary:

• Work Schedule: Monday-Friday
• 100% on-site

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 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 Catalents global biologics network and Wisconsins growing life sciences ecosystem.

The Product Development network supports development of biologic modalities (mAbs novel protein modalities mRNA exosomes enzymes viral proteins) frominitialearly 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 Senior Associate Scientist will perform a variety of laboratory procedures in Downstream Process Development. The position will perform daily work assignments accurately and ina timelyand safe manner. The Senior Associate Scientist will independently evaluateselectand apply standardized scientific and techniques to assignments of moderate complexity involving potentially conflicting design requirements unavailability of materials or processes etc. The Senior Associate Scientist seeks continual improvement of work practices from experience with moderate-sized projects; develops extensions to existing methods and protocols.

The Role:

• Execute and support downstream process development activities including protein purification chromatography filtration clarification column packing and tangential flow filtration at small and pilot scale.
• Independently design execute and analyze experiments including Design of Experiments (DOE) process characterization and scale-down model qualification.
• Apply advanced knowledge of protein purification techniques and analytical methods including HPLC ELISA and gel electrophoresis.
• Analyze and interpret experimental and manufacturing data perform process trending and statistical analysis and provide recommendations based on results.
• Author and review technical documentation including protocols reports batch records and laboratory documentation in compliance with Good Documentation Practices (GDP).
• Troubleshoot process equipment and experimental issues identify root causes and implement corrective actions to support project success.
• Lead or support innovation initiatives process improvements and special client projects while maintaining project timelines and deliverables.
• Perform routine laboratory operations including equipment maintenance buffer preparation sample shipment coordination inventory management and laboratory housekeeping.
• Collaborate cross-functionally with scientists manufacturing teams and clients to support process development goals and ensure high-quality project execution.
• Mentor junior team members and actively participate in team meetings knowledge sharing and continuous improvement efforts.
• Other duties as assigned

The Candidate:

• Bachelors degree in Biotechnology or STEM discipline and a minimum of 3 years related experience OR
• Masters degree in Biotechnology or STEM discipline and 0-3 years related experience.
• Aseptic technique experience
• Process scale chromatography and filtration (viral chromatography tangential flow normal flow) experience
• Knowledge and experience working in a cGMP environment is preferred
• Operating maintaining and troubleshooting chromatography workstations and process skids for purification and filtration preferably in an industrial setting
• Knowledge and experience in working in a cGMP environment is preferred
• Good documentation practices (GDP)
• Experience writing standard operating procedures

Why you should join Catalent:

• Potential for career growth on an expanding team
• Abundance of cross-functional exposure to other areas within the organization
• 152 hours of paid time off annually 8 paid holidays
• Day one benefits! Medical dental vision and 401K benefits effective on your first day

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability you may submit your request by sending an email and confirming your request for an accommodation and include the job number title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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