Scientist - Process Development, Upstream

Catalent Pharma Solutions; Alabama; On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical coverage

401(k) with match

Tuition reimbursement

Paid time off

Professional development

Job summary

Catalent Madison is seeking a Scientist, Process Development – Upstream to join the Late-Phase/Process Characterization Upstream Development team in Madison, WI. The role focuses on designing and executing upstream characterization studies for mammalian cell culture, utilizing DOE, scale-down models, and automated bioreactor systems to support development and regulatory readiness.

The candidate will contribute to data analysis, technical writing, and collaboration with technology transfer,

Qualifications

• Experience with upstream process development and biologics development activities.

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.
• Apply DOE and statistical tools to evaluate process performance and establish process understanding.
• Use scale-down models and automated bioreactor systems to support characterization and commercialization activities.
• Analyze data and prepare technical conclusions for project decisions and regulatory filings.
• Author and review study protocols, reports, SOPs, and regulatory-supporting documents.

Skills

Upstream process development

Mammalian cell culture

Bioreactor operations

Design of Experiments (DOE)

Statistical data analysis

Technical writing

Education

Bachelor's in STEM

Master's in STEM

PhD in related field

Tools

Ambr 250

Job description

Scientist - Process Development, Upstream

Madison, Wisconsin, United States

Aug 24, 2026

Scientist – Process Development, Upstream

Catalent 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,validationreadiness, and regulatory submissions. The successful candidate will combine strong laboratoryexpertise, scientific rigor, data analysis, and technical writing skills to deliver high-quality development solutions for client programs.

About Catalent Madison

Catalent's Madison, Wisconsin facility isa state-of-the-artbiologicsdevelopment 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 proprietaryGPEx® andGPEx® 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 globalbiologicsnetwork while supporting Wisconsin's growing life sciences industry.

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 andestablishprocess 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'sdegree 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 relatedbiologicsdevelopment 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,identifyprocess improvements, and recommend technical solutions.

Proficiencywith Microsoft Office applications and laboratory or manufacturing software systems.

Preferred Qualifications

Experience with process characterization, process validation, or commercial manufacturing support activities.

ExperienceutilizingDesign 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.

Previousclient-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 companymatch.

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.

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 [e-mail] . 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.