Lead Downstream Biomanufacturing Supervisor - mRNA

Catalent Pharma Solutions; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

Catalent is seeking a Supervisor - Biomanufacturing, Downstream/mRNA in Madison, WI. You will lead the downstream team, ensuring manufacturing readiness, scheduling, and continuous improvement in a 24/7 operation, with a 6am–4pm Wednesday–Saturday shift.

Location is onsite and requires strong regulatory compliance experience. Responsibilities include overseeing operations, staff development, and cGMP documentation, with engagement in audits and cross-functional collaboration to meet client and

Qualifications

• Clear communication of technical information to varied audiences, ensure data integrity and regulatory compliance (cGMP, ICH, FDA, EMA).
• Influence, negotiate, and inspire stakeholders to drive complex decisions across teams.
• Leadership to design and guide strategic projects and continuous improvement.

Responsibilities

• Oversee all assigned manufacturing operations to ensure products are produced on schedule, within quality standards, and aligned with cost objectives.
• Lead, develop, and evaluate staff, addressing performance issues promptly and ensuring compliance with company policies and regulatory requirements.
• Communicate decisions, policies, and operational updates to personnel to support strong performance and engagement.
• Author, revise, and maintain cGMP documentation, including SOPs, Batch Production Records, forms, and job aids.
• Support internal, client, and regulatory audits by preparing documentation and ensuring operational readiness.
• Lead technical discussions, investigations, and project-related calls, providing SME for manufacturing activities.
• Maintain and strengthen the Quality System, including floor compliance, deviation investigations, and change control execution.
• Manage cleanroom operations, including 5S adherence, housekeeping, equipment cleaning, and review/sign-off of executed cGMP records.
• Oversee equipment readiness, including routine and preventive maintenance, qualification/validation activities, and support for technology transfer.
• Coordinate scheduling and resource allocation with leadership, drive continuous improvement initiatives, and provide shift or off-shift coverage as required.
• Other duties as assigned.

Skills

Leadership

Staff development

Communication

Regulatory knowledge

Project management

Education

Bachelor's degree in science

Master's degree in science

Job description

Catalent is seeking a Supervisor - Biomanufacturing, Downstream/mRNA in Madison, WI. You will lead the downstream team, ensuring manufacturing readiness, scheduling, and continuous improvement in a 24/7 operation, with a 6am–4pm Wednesday–Saturday shift.

Location is onsite and requires strong regulatory compliance experience. Responsibilities include overseeing operations, staff development, and cGMP documentation, with engagement in audits and cross-functional collaboration to meet client and