2nd Shift Upstream Biomanufacturing Lead

Ourlivesmadison; Madison, Northern (WI, KY); Hybrid; USD 110,000 - 145,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Tuition Reimbursement

PTO & Holidays

Job summary

Catalent and its Madison site are seeking a Supervisor – Biomanufacturing, Upstream to oversee operations, lead staff, and ensure quality, schedule, and cost objectives. This role is based onsite in Madison, WI, on the 2nd shift (2pm-12am, Wed-Sat).

You will manage cleanroom operations, equipment readiness, and drive continuous improvement while ensuring regulatory compliance and supporting audits and technical discussions.

Qualifications

• Bachelor’s or Master’s in science/engineering/biomanufacturing with GMP exposure.
• Clear communicator of technical information to diverse audiences.
• Ability to lead multiple concurrent activities and maintain data integrity.

Responsibilities

• Oversee 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 current Good Manufacturing Practice (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 subject‑matter expertise 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

Skills

GMP

Leadership

cGMP

Regulatory knowledge

Education

Master’s degree with 2+ years

Bachelor’s degree with 4+ years

Job description

Catalent and its Madison site are seeking a Supervisor – Biomanufacturing, Upstream to oversee operations, lead staff, and ensure quality, schedule, and cost objectives. This role is based onsite in Madison, WI, on the 2nd shift (2pm-12am, Wed-Sat).

You will manage cleanroom operations, equipment readiness, and drive continuous improvement while ensuring regulatory compliance and supporting audits and technical discussions.