Senior Associate Scientist, Downstream Process Development

Senior Associate Scientist, Downstream Process Development

Position Summary:

• Work Schedule: Monday-Friday
• 100% 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 Senior Associate Scientist will perform a variety of laboratory procedures in Downstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner. The Senior Associate Scientist will independently evaluate, select and 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:

• Bachelor's degree in Biotechnology or STEM discipline and a minimum of 3 years related experience, OR
• Master’s 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 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.

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 DisabilityAccommodations@catalent.com. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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