Manager - Process Development, Downstream

Job Summary

Manager – Process Development, Downstream

Position Summary:

Work Schedule:

M‑F 8am‑5pm. 100% on‑site. Catalent Biologics is seeking an experienced Downstream Process Development Manager to lead late‑stage process development and process characterization activities for protein biologics. The role provides 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 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.
• 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.

• 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; or B.S./B.A. with minimum of 10 years’ experience.
• 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.
• 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, Manufacturing, Quality, and Analytical Development to drive aligned technical and execution strategies.
• People and technical leadership experience, including mentoring scientists and managing execution across multiple complex programs.
• Experience…