Director - Process Development, Downstream & Upstream

Director, Process Development

Catalent's Madison facility is a state-of-the-art biologics development and manufacturing site focused on delivering advanced solutions for biopharmaceutical products. The site features modern laboratories and flexible manufacturing spaces designed to support a wide range of biologics programs, from early development through commercial production. With cutting-edge technology and a collaborative environment, the Madison location plays a key role in driving innovation and quality in the life sciences industry.

This dynamic setting offers employees the opportunity to work on impactful projects that help bring life-changing therapies to patients worldwide.

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.

Location:

Madison, WI

100% Onsite

• Work closely with the Manufacturing Sciences group to ensure successful transfer of processes from PD into manufacturing in order to support early phase through commercial manufacturing activities.
• Work closely with prospective and existing clients, as well as Project Management, to ensure client expectations, scheduling, and timelines are met.
• Apply technical, functional, business, and industry expertise to design experiments and define project scopes; provide scientific and strategic consultation to site and executive leadership; and lead multiple functions and focus areas across site disciplines.
• Actively define and execute on strategic direction of the department by recommending expansion or curtailment of investigations based on experimental results or scientific information.
• Lead Process Development teams and manage 2–10 direct reports which may include principal level scientists and people leaders.
• Support manufacturing through process transfer, technology transfer, investigations, and facility fit assessments.
• Direct the development of scalable processes to support optimal expression, purification, and product quality attributes for both antibodies, recombinant proteins, and other biomolecules.
• Responsible for execution of production batches and supporting manufacturing up to sX2000L scale in SUBs.
• Identify, evaluate, and execute on process improvements to increase existing capabilities.

• Bachelor's degree in STEM discipline with 15 years of biopharmaceutical manufacturing experience; OR Master's degree with 12 years' experience; OR PhD with 8 years' experience and 6+ years in leadership roles.
• Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
• Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
• Well organized with ability to handle and direct multiple activities within the site or across multiple sites simultaneously.
• Excellent written and verbal communication skills with internal and external customers.
• Ability to communicate complex technical information to non-technical audiences.
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

• 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.
• Strong coaching, mentoring, and talent development capabilities.
• Experience leading customer-facing technical discussions and issue resolution.
• Experience supporting production in single-use bioreactor environments.

• 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 7,000 life-saving and life-enhancing products to…