Manager - Process Development, Downstream

Manager - Process Development, Downstream

Position Summary:

• Work Schedule: M-F 8am-5pm
• 100% on-site

Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a global public company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.

Catalent Pharma Solutions in Madison, WI is hiring a Manager - Process Development, Downstream.

We are seeking an experienced Downstream Process Development Manager to lead late-stage process development and process characterization activities for protein biologics. The ideal candidate brings deep technical expertise in downstream unit operations and quality-by-design principles, along with hands-on experience supporting late-phase programs, PPQ readiness, and technology transfer into cGMP manufacturing. This role will provide technical leadership across cross-functional teams, ensuring robust process understanding, regulatory-ready documentation, and successful execution from clinical through commercial stages.

The Role:

• Supervise assigned team's daily work activities including workload, ensuring training, general guidance to direct reports and across functional groups, and serve as resource for technical/administrative problems
• Hire, train, motivate, lead, develop, and evaluate staff
• Mentor direct reporting people leaders on fundamentals of leadership and career development.
• Take corrective action as necessary on a timely basis and in accordance with company policy
• Ensure compliance with current federal, state, and local regulations. Consult with Human Resources Department as appropriate
• Ensure target timelines to deliver results are met and data integrity
• Interact with customers during meetings as a first line in escalations; provide responses to customer's questions
• Identify and implement new technology/instrumentation for continuous improvement of productivity and throughput
• Author and review technical documents such as Standard Operating Procedures (SOPs), study protocols, and reports
• Communicate effectively and follow detailed written and verbal instruction; ability to clearly communicate and provide mentorship to other groups and clients as necessary
• Ability to provide ideas and introduce new technology for process improvements with the goal of transfer to manufacturing
• Collaborate significantly with cross functional groups including Project Management, Manufacturing, Manufacturing Sciences, and Process Development
• Take responsibility for direct reports' performance by setting clear goals and expectations, tracking
  progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly
• Work with, coach, and support direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development
• All other duties as assigned

The Candidate:

• PhD in Biotechnology or related field with minimum of 4 years' experience in related laboratory work/laboratory leadership role; or
• M.S./M.A. in Biotechnology or related field with minimum of 8 years' experience in related laboratory work/laboratory leadership role; or
• B.S./B.A. in Biotechnology or related field with minimum of 10 years' experience in related laboratory work/laboratory leadership role

• Leadership experience minimum 4 years

• Downstream process development and scale-up for protein biologics, including chromatography, filtration (UF/DF, normal flow), viral clearance, and formulation unit operations

• Leadership experience directing personnel and organizational group management, including mentoring and training staff members cross-functionally

• Experience in applying GMP/GDP in compliance with international regulatory expectations and requirements is a plus

• Process characterization and validation support, including identification of CPPs, CQAs, and establishment of control strategies aligned with QbD principles

• Late-phase and PPQ readiness support, including authoring or reviewing development reports, characterization protocols, validation strategies, and regulatory-supporting documentation

• Technology transfer to cGMP manufacturing, including scale-down model definition, risk assessments, and troubleshooting during manufacturing execution

• Strong working knowledge of cGMP expectations, data integrity, and good documentation practices for biologics manufacturing

• Application of statistical and experimental design tools (e.g., DoE) to support process robustness, lifecycle management, and comparability assessments

• Cross-functional leadership working with MS&T,…