Biologics Process Development Scientist (Lifecycle)

Catalent; Madison (WI); On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Day-one medical, dental, and vision

401(k) with company match

Tuition reimbursement

Paid time off and holidays

Professional development opportunities

Job summary

Catalent is seeking a Scientist – Process Development, Drug Substance Lifecycle to join our team in Madison, Wisconsin. In this role, you will provide technical expertise and lifecycle support for biologics programs as they progress through development, validation, commercialization, and post-approval manufacturing.

You'll collaborate across Manufacturing, Quality, MS&T, Regulatory, Project Management, and client teams to drive successful program execution and continuous process improvement.

Qualifications

• PhD in a STEM discipline or Master's with 3+ years of industry experience; or Bachelor's with 6+ years.
• Experience in biologics development, validation, or commercial manufacturing is preferred.
• Experience working in cGMP environments and with lifecycle management concepts.

Responsibilities

• Lead process characterization activities for development, validation, and commercial programs.
• Support process validation, continued process verification, and lifecycle change management.
• Analyze process data, identify improvements, and drive risk reduction.
• Act as SME for assigned programs and client interactions.
• Prepare and review technical protocols, reports, and regulatory documents.
• Support investigations, CAPAs, change controls, and quality system activities.

Skills

Analytical thinking

Attention to detail

Education

PhD in STEM

Master's degree + 3 years of experience

Bachelor's degree + 6 years of experience

Tools

JMP

Minitab

Excel

Job description

Catalent is seeking a Scientist – Process Development, Drug Substance Lifecycle to join our team in Madison, Wisconsin. In this role, you will provide technical expertise and lifecycle support for biologics programs as they progress through development, validation, commercialization, and post-approval manufacturing.

You'll collaborate across Manufacturing, Quality, MS&T, Regulatory, Project Management, and client teams to drive successful program execution and continuous process improvement.