Scientist - Process Development, UpstreamCatalent is seeking a
Scientist, Process Development - Upstream to join our
Late-Phase/Process Characterization Upstream Development team supporting biologics programs as they advance toward validation and commercial manufacturing.
This role focuses on the design and execution of process characterization and optimization studies using scale-down models and statistical approaches to support process understanding, validation readiness, and regulatory submissions. The successful candidate will combine strong laboratory expertise, scientific rigor, data analysis, and technical writing skills to deliver high-quality development solutions for client programs.
Location: 100% Onsite at our facility in Madison, Wisconsin
Shift: Monday - Friday, First Shift
Key Responsibilities - Design and execute upstream process characterization, optimization, and validation support studies for mammalian cell culture processes.
- Perform mammalian cell culture activities including cell bank thawing, seed train expansion, small-scale bioreactor operations, and analytical testing.
- Leverage statistical tools and Design of Experiments (DOE) methodologies to evaluate process performance and establish process understanding.
- Utilize scale-down models and automated bioreactor systems to support process characterization and commercialization activities.
- Analyze experimental data and prepare technical conclusions to support project decision-making and regulatory filings.
- Author and review technical documents including study protocols, reports, SOPs, and regulatory-supporting documentation.
- Collaborate closely with multidisciplinary teams supporting technology transfer, validation, manufacturing, and client programs.
- Contribute to continuous improvement initiatives and support training and mentoring activities within the department.
- 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 with process characterization, process validation, or commercial manufacturing support activities.
- Experience utilizing Design of Experiments (DOE) and statistical analysis tools.
- Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar platforms.
- Experience supporting regulatory submissions or generation of regulatory-supporting technical documentation.
- Experience in a GMP-regulated biotechnology, pharmaceutical, or CDMO environment.
- Previous client-facing experience.
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 match.
- Tuition reimbursement and professional development opportunities.
- Generous paid time off and holiday schedule (152 hours + 8 holidays)
- Collaborative, mission-driven culture focused on improving patient outcomes worldwide.
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.
