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.

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.

• Supervise assigned team’s daily work activities, ensuring training, general guidance to direct reports and cross‑functional groups, and serve as a 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 in a timely manner and in accordance with company policy.
• Ensure compliance with current federal, state, and local regulations and consult with Human Resources Department as appropriate.
• Ensure target timelines to deliver results are met and data integrity is maintained.
• Interact with customers during meetings as a first line in escalations; provide responses to customer 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 instructions; provide mentorship to other groups and clients as necessary.
• Introduce new technology and ideas for process improvements aimed at 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, providing constructive feedback, and addressing performance concerns promptly.
• Coach and support direct reports in developing knowledge, skills, and abilities to improve performance and career development.
• Perform other duties as assigned.

• PhD in Biotechnology or related field with minimum of 4 years of laboratory work or laboratory leadership experience; or
• M.S./M.A. in Biotechnology or related field with minimum of 8 years of laboratory work or laboratory leadership experience; or
• B.S./B.A. in Biotechnology or related field with minimum of 10 years of laboratory work or laboratory leadership experience.
• Leadership experience of at least 4 years.
• Experience in downstream process development and scale‑up for protein biologics, including chromatography, filtration (UF/DF, normal flow), viral clearance, and formulation unit operations.
• Experience directing personnel and managing organizational groups, including mentoring and training staff cross‑functionally.
• Knowledge of GMP/GDP and international regulatory expectations 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…