Downstream Process Development Manager — Lead & Scale

Catalent Pharma Solutions; Alabama; On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

PTO & holidays

401K match

Medical, dental and vision benefits

Tuition Reimbursement

Job summary

Catalent Pharma Solutions in Madison, WI is seeking a Manager – Process Development, Downstream to lead late‑stage development and characterization for protein biologics. The role requires deep downstream expertise, GMP compliance, and robust cross‑functional leadership across MS&T, Manufacturing, and Quality.

The ideal candidate will support PPQ readiness, scale‑up, technology transfer to cGMP manufacturing, and drive disciplined documentation and process control strategies aligned with QbD

Qualifications

• PhD in Biotechnology or related field with minimum of 4 years’ experience in related laboratory work/laboratory leadership role; or MS/MA 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, 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 interacting and liaising with internal and external clients, customers, and/or suppliers required
• Experience managing continuous improvement initiatives, lean principles, and 5S is preferred

Responsibilities

• 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

Skills

Downstream process development

Team leadership

cGMP knowledge

DoE & experimental design

Technology transfer

Regulatory documentation

Education

PhD in Biotechnology or related field

MS/MA in Biotechnology or related field with leadership experience

BS/BA in Biotechnology or related field with leadership experience

Tools

Chromatography

Filtration UF/DF

Viral clearance

Job description

Catalent Pharma Solutions in Madison, WI is seeking a Manager – Process Development, Downstream to lead late‑stage development and characterization for protein biologics. The role requires deep downstream expertise, GMP compliance, and robust cross‑functional leadership across MS&T, Manufacturing, and Quality.

The ideal candidate will support PPQ readiness, scale‑up, technology transfer to cGMP manufacturing, and drive disciplined documentation and process control strategies aligned with QbD