Biopharma Process Development & Manufacturing Lead

UWMSN University of Wisconsin Madison; Wisconsin; On-site; USD 81,000 - 99,000; Full time

Benefits offered by this job

Generous vacation and paid time off

Retirement benefits

Competitive insurances

Job summary

The University of Wisconsin–Madison’s Waisman Center seeks a Process Development and Manufacturing Manager to lead biomanufacturing operations, including upstream/downstream processes such as mRNA, lipid nanoparticle, and plasmid DNA manufacturing, under cGMP guidelines.

You'll develop SOPs, validate processes, manage budgets, supervise at least 2 FTE, and coordinate with stakeholders across clinical trial manufacturing. This role requires after-hours response on a rotating schedule.

Qualifications

• Five years of biopharma, drug substance/product, or RNA/LNP-based development and manufacturing experience.
• Experience with SOPs, manufacturing documentation, and cGMP manufacturing of biopharmaceuticals.

Responsibilities

• Assist with budgets and project components.
• Develop and execute scalable manufacturing processes.
• Oversee client-specific projects and provide timely updates to stakeholders.
• Act as SME and unit liaison for manufacturing operations.
• Prepare and present manufacturing reports and SOPs; develop MF formulations.
• Oversee cGMP manufacturing for biopharmaceuticals in clinical trials.
• Supervisory authority over at least 2.0 FTE employees.

Skills

Biopharma

cGMP

Project management

Supervision

Budget management

Education

Bachelor's Degree

Biochemical Engineering / Cellular Biology / Molecular Biology / related field

Master’s Degree + 5 years in biologics (preferred)

Tools

Chromatography

TFF systems

Automated biomanufacturing equipment

Job description

The University of Wisconsin–Madison’s Waisman Center seeks a Process Development and Manufacturing Manager to lead biomanufacturing operations, including upstream/downstream processes such as mRNA, lipid nanoparticle, and plasmid DNA manufacturing, under cGMP guidelines.

You'll develop SOPs, validate processes, manage budgets, supervise at least 2 FTE, and coordinate with stakeholders across clinical trial manufacturing. This role requires after-hours response on a rotating schedule.