Director - Process Development, Downstream & Upstream

Catalent; Madison (WI); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Defined career path

Diversity and inclusion

Paid time off

Medical/dental/vision benefits

Tuition Reimbursement

Job summary

Catalent is seeking a Director of Process Development in Madison, WI, a 100% onsite role. You will lead the Process Development organization to advance biologics processes from early phase through commercial readiness and support tech transfer into manufacturing.

The role requires 15+ years in STEM with leadership, deep biologics expertise, and strong communication. Shift is 9am–5pm, location Madison, WI. Catalent offers career growth and comprehensive benefits.

Qualifications

• Bachelor’s degree in STEM with 15+ years related experience.
• Master’s degree in STEM with 12+ years related experience.
• Doctorate degree in STEM with 8+ years related experience.
• 6+ years of leadership experience.
• Deep understanding of biologics process development and manufacturing.
• Experience in drug development and lifecycle support.
• Excellent written and verbal communication skills.
• Ability to communicate complex technical information to non‑technical audiences.
• Demonstrable leadership experience at Catalent may be considered in place of external experience.

Responsibilities

• Lead Process Development teams and manage 2–10 direct reports.
• Define and execute department strategy based on scientific and business priorities.
• Oversee development of scalable expression, purification, and product quality processes.
• Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
• Partner with clients, project management, and leadership to meet timelines and expectations.
• Lead cross‑functional and multi‑site strategic initiatives and process improvement efforts.

Skills

Leadership

Communication

Cross-functional collaboration

Strategic thinking

Biologics process development

Technology transfer

Project management

Education

Bachelor’s degree in STEM

Master’s degree in STEM

Doctorate in STEM

Job description

About Site

Catalent’s Madison, Wisconsin site is a state‑of‑the‑art biologics development and manufacturing facility supporting customers from research through early‑ and mid‑stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700‑square‑foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single‑use systems to enable rapid scale‑up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high‑yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.

Position Summary

We have an opportunity for a Director, Process Development to join our team and lead the Process Development organization. This role is responsible for advancing biologics process development from early‑phase programs through commercial readiness while ensuring successful transfer into manufacturing. You will deliver scalable upstream and downstream processes, support manufacturing execution, and align cross‑functional teams and clients to meet development timelines and business objectives. This position provides technical, operational, and people leadership across multiple functions and sites, driving strategic initiatives, process improvements, and organizational performance.

Shift: 9am‑5pm

Location: Madison, WI (100% Onsite)

The Role

• Lead Process Development teams and manage 2–10 direct reports.
• Define and execute department strategy based on scientific and business priorities.
• Oversee development of scalable expression, purification, and product quality processes.
• Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
• Partner with clients, project management, and leadership to meet timelines and expectations.
• Lead cross‑functional and multi‑site strategic initiatives and process improvement efforts.

Minimum Requirements

• Bachelor’s degree in a STEM discipline and 15+ years related experience.
• or Master’s degree in a STEM discipline and 12+ years related experience.
• or Doctorate degree in a STEM discipline and 8+ years related experience.
• 6+ years of leadership experience.
• Deep understanding of biologics process development and manufacturing.
• Experience in drug development and lifecycle support.
• Excellent written and verbal communication skills.
• Ability to communicate complex technical information to non‑technical audiences.
• Demonstrable leadership experience at Catalent may be considered in place of external experience.

Preferred Skills & Background

• Experience leading multi‑site strategic initiatives.
• Expertise in mammalian cell culture and upstream process development.
• Expertise in downstream process development and process characterization.
• Experience supporting technology transfer and commercial manufacturing readiness.
• Strong stakeholder management and executive influence skills.
• Ability to manage multiple priorities across sites and functions.
• Experience with process optimization and continuous improvement initiatives.
• Strong coaching, mentoring, and talent development capabilities.
• Experience leading customer‑facing technical discussions and issue resolution.
• Experience supporting production in single‑use bioreactor environments.

Benefits

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.

Equal Opportunity Statement

Catalent is an Equal Opportunity Employer, including disability and veterans.