Manufacturing Lead: Device Assembly & Packaging (Hybrid)

Amgen; New Albany (OH); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Retirement plan

Medical/Dental/Vision coverage

Life & Disability insurance

Bonus program

Stock-based incentives

Paid time off (PTO)

Flexible work models

Job summary

Amgen Inc. (IR) in the United States is seeking a Manufacturing Senior Associate to manage and lead a device assembly and packaging line, ensuring full cGMP compliance and timely production.

The role involves supervising technicians, equipment setup, troubleshooting, and safety adherence across the manufacturing floor. The candidate will collaborate with Quality, Engineering and Manufacturing Support, drive continuous improvement, and participate in deviations, CAPA, and change controls.

Qualifications

• High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience
• Or Associate’s + 2 years biotech or pharmaceutical manufacturing, process development or quality experience
• Or Bachelor’s + 6 months biotech or pharmaceutical manufacturing, process development or quality experience
• Or Master’s degree may substitute for experience when applicable
• Degree in Chemical/Industrial Engineering or Life Sciences is preferred
• Experience with cGMP and pharmaceutical/biotech packaging equipment is desirable
• Experience leading cross-functional teams and managing multiple priorities

Responsibilities

• Manage and lead device assembly & packaging line operations.
• Maintain production in full cGMP compliance.
• Supervise and develop technicians and oversee equipment to meet production schedules.
• Lead floor manufacturing operations including equipment setup, operation and troubleshooting.
• Provide training and technical support on processes and equipment.
• Collaborate with Quality, Engineering and Manufacturing Support to resolve events.
• Support CAPA, deviations, and change controls.
• Write and revise SOPs and manufacturing documents.

Skills

Cross-functional teamwork

Change management

Problem solving

Communication

Education

Bachelor's in Chemical Engineering

Bachelor's in Industrial Engineering

Bachelor's in Life Sciences

Tools

MES

LIMS

Maximo

CCMS

SAP

Job description

Amgen Inc. (IR) in the United States is seeking a Manufacturing Senior Associate to manage and lead a device assembly and packaging line, ensuring full cGMP compliance and timely production.

The role involves supervising technicians, equipment setup, troubleshooting, and safety adherence across the manufacturing floor. The candidate will collaborate with Quality, Engineering and Manufacturing Support, drive continuous improvement, and participate in deviations, CAPA, and change controls.