Biologics Process Development Manager

University of Wisconsin; Bowens Addition (WI); On-site; USD 81,000 - 99,000; 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 in a cGMP setting. The role supports downstream and upstream processes, SOP development, validation, and regulatory-compliant documentation for Phase I/II clinical trials.

Responsibilities include budget oversight, project supervision, and engaging with stakeholders.

Qualifications

• Five years of experience in biopharma or RNA/LNP development and manufacturing.
• Experience with regulatory guidelines and CMC expectations is preferred.
• Ability to manage projects and supervise a team in a collaborative environment.

Responsibilities

• Assist with budgets and resource planning for projects.
• Develop scalable manufacturing processes ensuring quality and purity.
• Oversee client projects and report progress to stakeholders.
• Serve as SME and unit liaison for manufacturing programs.
• Prepare manufacturing documentation and SOPs.
• Oversee cGMP manufacturing of biopharmaceuticals for clinical trials.
• Supervise a team of at least 2 FTE employees and manage performance.

Skills

Biopharma experience

Project management

Regulatory knowledge

Supervision

Education

Bachelor's Degree

Master's Degree preferred

Tools

Liquid chromatography

TFF systems

cGMP manufacturing

Job description

The Waisman Center at the University of Wisconsin–Madison seeks a Process Development and Manufacturing Manager to lead manufacturing operations for biopharmaceuticals in a cGMP setting. The role supports downstream and upstream processes, SOP development, validation, and regulatory-compliant documentation for Phase I/II clinical trials.

Responsibilities include budget oversight, project supervision, and engaging with stakeholders.