Scientist - Process Development, Upstream

Overview

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. Roles may support projects across multiple development stages, including early‑phase process development, process characterization, validation readiness, and clinical/commercial manufacturing support. Candidates may be assigned to different upstream development teams based on business needs and experience.

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

Location:

100% onsite at Catalent’s Madison, WI facility.

• Design and execute upstream process development studies to support 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 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; author or review technical documents including protocols, reports, SOPs, and regulatory‑supporting documentation.
• Serve as a technical resource for internal teams and external clients, communicating project progress and supporting project execution.
• Contribute to continuous improvement initiatives, laboratory operations, and the training/mentoring of junior team members.
• Other responsibilities as needed.

• Required:
  
  Bachelor’s degree in a STEM discipline with a minimum of 6 years of relevant experience, or Master’s degree with a minimum of 3 years of 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 (protocols, reports, SOPs).
• Demonstrated analytical and problem‑solving skills with the ability to interpret data, identify process improvements, and recommend technical solutions.
• Proficiency with Microsoft Office and laboratory or manufacturing software systems.

• 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 (e.g., Am ® 250) or similar technologies.
• Experience authoring technical reports, protocols, and regulatory‑supporting documentation.
• Experience in a GMP‑regulated biopharmaceutical, biotechnology, or CDMO environment; client‑facing experience.

Location:

100% on site at Catalent’s Madison, Wisconsin facility. Shift: Monday – Friday, First Shift.

• Competitive compensation package with 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.
• Collaborative, mission‑driven culture focused on improving patient outcomes.

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 emailing Disabili with the job number, title and location. This option is reserved for individuals who require accommodation due to a disability.