Downstream Biomanufacturing Supervisor, mRNA (Night Shift)

Catalent, Inc.; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Tuition Reimbursement

Competitive PTO

Career growth opportunities

Job summary

Catalent, Inc. in Madison, Wisconsin is seeking a Supervisor - Biomanufacturing, Downstream/mRNA to lead the Downstream/mRNA team in a 24/7 operation. You will oversee chromatography, filtration, viral reduction, and bulk drug substance filling in a cGMP environment, ensuring readiness and adherence to production schedules.

This role requires strong leadership, communication, and regulatory compliance knowledge (cGMP, ICH, FDA). Shift: Sunday–Wednesday, 10pm–8am, onsite at Madison site.

Qualifications

• High School Diploma plus 6 years GMP experience.
• Master’s degree with 2+ years OR Bachelor’s/Associate with 4+ years.
• Ability to clearly communicate technical information and ensure regulatory compliance (cGMP, ICH, FDA, EMA).
• Proven leadership to drive continuous improvement and manage multiple activities.

Responsibilities

• Oversee manufacturing operations to meet schedule, quality, and cost objectives.
• Lead staff development, address performance, and ensure regulatory compliance.
• Maintain cGMP documentation including SOPs and batch records.
• Support audits and lead technical discussions and investigations.
• Manage cleanroom operations, equipment readiness, and maintenance.
• Coordinate scheduling and resources with leadership and provide coverage as needed.

Skills

Leadership

Communication

Cross-functional coord

Process improvement

Education

Bachelor’s or Associate degree plus relevant experience

Master’s degree with 2+ years OR Bachelor’s/Associate with 4+ years

Job description

Catalent, Inc. in Madison, Wisconsin is seeking a Supervisor - Biomanufacturing, Downstream/mRNA to lead the Downstream/mRNA team in a 24/7 operation. You will oversee chromatography, filtration, viral reduction, and bulk drug substance filling in a cGMP environment, ensuring readiness and adherence to production schedules.

This role requires strong leadership, communication, and regulatory compliance knowledge (cGMP, ICH, FDA). Shift: Sunday–Wednesday, 10pm–8am, onsite at Madison site.