Scientist - Process Development, Upstream

Catalent is seeking Scientists, Process Development - Upstream to support the development, optimization, characterization, and transfer of mammalian cell culture processes for biologics manufacturing. Scientists in this role may support projects across multiple development stages, including early-phase process development, process characterization, validation readiness, and clinical/commercial manufacturing support.

Successful candidates may be assigned to different upstream development teams based on business needs and experience. Opportunities include support of early-stage process development programs as well as late-phase process characterization, validation, and commercial manufacturing initiatives.

The successful candidate will combine strong laboratory expertise with data analysis, technical problem-solving, technical writing, and cross-functional collaboration to deliver high-quality process solutions for internal and client programs.

Location: 100% Onsite at our facility in Madison, Wisconsin
Shift: Monday - Friday, First Shift

Key Responsibilities

• Design and execute upstream process development studies supporting biologics programs from early development through commercial readiness.

• Perform mammalian cell culture activities including cell bank thawing, seed train expansion, bioreactor operations, and analytical testing.

• Support process optimization, process characterization, scale-up, validation readiness, and technology transfer activities using platform methods and statistical tools, including Design of Experiments (DOE).

• Analyze experimental data and communicate results through presentations, technical recommendations, and project updates.

• Maintain GMP-compliant documentation and author or review technical documents including protocols, reports, SOPs, and regulatory-supporting documentation.

• Serve as a technical resource for internal teams and external clients by communicating project progress, presenting results, and supporting project execution.

• Contribute to continuous improvement initiatives, laboratory operations, and the training and mentoring of junior team members.

• 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 in upstream biologics process development, process characterization, or process optimization.

• Experience with technology transfer, validation support, scale-up, or commercial manufacturing programs.

• Working knowledge of statistical analysis tools and Design of Experiments (DOE).

• Experience with automated small-scale bioreactor systems such as Ambr® 250 or similar technologies.

• Experience authoring technical reports, protocols, and regulatory-supporting documentation.

• Experience in a GMP-regulated biopharmaceutical, biotechnology, 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.