Director Process Development, Downstream & Upstream

About Site

Catalents Madison Wisconsin site is a stateoftheart biologics development and manufacturing facility supporting customers from research through early and midstage clinical production. Located at 726 Heartland Trail in Madison the approximately 102700squarefoot GMP facility specializes in mammalian cell line engineering drug substance biomanufacturing and biopharmaceutical development utilizing flexible singleuse systems to enable rapid scaleup and customization. The site is home to Catalents proprietary GPEx and GPEx Lightning technologies which are used to generate highyielding mammalian cell lines for biologic therapies and supports production scales ranging from 50 to 4000 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 Catalents global biologics network and Wisconsins 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 210 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.

The Candidate

Minimum Requirements

• Bachelors degree in a STEM discipline and 15 years related experience.

• OR Masters 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 (including but not limited to participation in Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) 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.

Why You Should Join Catalent

• 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.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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.

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 . 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.

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