Upstream Biomanufacturing Supervisor - Lead & Optimize

Catalent Pharma Solutions; Alabama; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Defined career path

Diverse, inclusive culture

Career growth opportunities

Paid time off + holidays

Medical, dental & vision benefits from

Tuition Reimbursement

Job summary

Catalent Pharma Solutions is seeking a Supervisor - Biomanufacturing, Upstream to oversee Madison, WI-based operations. You will lead and develop staff, ensure products meet quality and schedule goals, and support audits and regulatory discussions.

This role requires strong GMP knowledge, cGMP documentation management, and the ability to drive continuous improvement across cleanroom operations and cross-functional teams. Shift: 2nd shift, 2pm-12am, 4x10, onsite.

Qualifications

• Master’s degree with 2+ years or a Bachelor’s degree with 4+ years in a scientific, engineering, or biomanufacturing field.
• Experience in GMP/cGMP environments and ensuring regulatory compliance (FDA/ICH/EMA).
• Ability to communicate complex technical information clearly to diverse audiences and to mentor staff.

Responsibilities

• Oversee 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 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 leading technical discussions
• Maintain and strengthen the Quality System, including deviation investigations, and change control execution
• Manage cleanroom operations, including 5S, housekeeping, equipment cleaning, and qualification/validation activities
• Coordinate scheduling and resource allocation with leadership, drive continuous improvement, and provide shift coverage as required

Skills

Leadership

Regulatory awareness

GMP/cGMP experience

Staff development

Audits and inspections

Communication

Cross-functional collaboration

Education

Master’s degree in science/engineering/biomanufacturing

Bachelor’s degree with 4+ years GMP experience

Job description

Catalent Pharma Solutions is seeking a Supervisor - Biomanufacturing, Upstream to oversee Madison, WI-based operations. You will lead and develop staff, ensure products meet quality and schedule goals, and support audits and regulatory discussions.

This role requires strong GMP knowledge, cGMP documentation management, and the ability to drive continuous improvement across cleanroom operations and cross-functional teams. Shift: 2nd shift, 2pm-12am, 4x10, onsite.