Biopharma Process Development & Manufacturing Manager

University of Wisconsin-Madison; Madison (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

The Waisman Center at the University of Wisconsin–Madison seeks a Process Development and Manufacturing Manager to lead manufacturing operations for biopharmaceuticals used in Phase I/II trials. The role covers process development, SOPs, and cGMP compliance, with responsibility for budgets and staff supervision in a collaborative, interdisciplinary setting.

Qualifications include five years in biopharma development/manufacturing, expertise in RNA/LNP processes, and experience supervising teams.

Qualifications

• Five years of biopharma experience in drug substance or product development/manufacturing is required.
• Experience with RNA/LNP or related biologics development is beneficial.
• Supervisory experience is preferred.
• Working knowledge of current cGMP guidelines is required.

Responsibilities

• Assists with development and auditing of project-specific budgets.
• Develops and executes manufacturing processes to produce scalable, repeatable methods for quality and purity.
• Oversees and manages client-specific projects and provides updates on components and timelines to stakeholders.
• Serves as a subject matter expert and unit liaison.
• Completes manufacturing documentation, prepares reports, and presents findings to internal and external audiences.
• Develops Standard Operating Procedures (SOPs) and Manufacturing Formulas (MFs).
• Oversees process development and cGMP manufacturing of biopharmaceuticals for clinical trials.
• Exercises supervisory authority over at least 2.0 FTE employees.

Skills

Biopharma experience

RNA/LNP development

Supervisory experience

cGMP manufacturing

Process development

Education

Bachelor's degree required

Master's degree preferred

Related field degree preferred

Job description

The Waisman Center at the University of Wisconsin–Madison seeks a Process Development and Manufacturing Manager to lead manufacturing operations for biopharmaceuticals used in Phase I/II trials. The role covers process development, SOPs, and cGMP compliance, with responsibility for budgets and staff supervision in a collaborative, interdisciplinary setting.

Qualifications include five years in biopharma development/manufacturing, expertise in RNA/LNP processes, and experience supervising teams.