Sr Associate Manufacturing - Line Lead (12hr Shift Evening 6:00pm - 6:00am)

Amgen • New Albany, OH

127d • Hybrid

About The Position

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines. In this role, you will be managing and leading all aspects of a device assembly & packaging line, maintaining production in full cGMP compliance. You will assist with supervising and developing technicians while overseeing production equipment to ensure production schedules are completed. You will lead manufacturing operations on the production floor, perform equipment setup, operation, and troubleshooting, and ensure all safety and compliance procedures are followed at all times.

Requirements

• High school/GED + 4 years biotech or pharmaceutical manufacturing, process development or quality experience.
• Associate's + 2 years biotech or pharmaceutical manufacturing, process development or quality experience.
• Bachelor's + 6 months biotech or pharmaceutical manufacturing, process development or quality experience.
• Master's degree.

Nice To Haves

• Degree in Chemical Engineering, Industrial Engineering or Life Sciences.
• Technical understanding of pharmaceutical/biotech packaging equipment and processes.
• Experience with Current Good Manufacturing Practices (cGMP).
• Ability to be flexible and manage change.
• Experience participating in and leading cross-functional teams.
• Experience in managing multiple, competing priorities in a fast-paced environment.
• Strong scientific, technical interactions with partner organizations.
• Experience in GMP Tech Support roles, GMP operations, process development or scheduling.
• Experience with Commissioning and Qualification, New Product Introduction, Cleaning Validation, and Process Performance Qualification.
• Background in lean manufacturing methodologies and operational excellence.
• Expertise in electronic systems used in manufacturing (MES, LIMS, Maximo, CCMS, SAP).

Responsibilities

• Manage and lead all aspects of a device assembly & packaging line.
• Maintain production in full cGMP compliance.
• Assist with supervising and developing technicians.
• Oversee production equipment to ensure production schedules are completed.
• Lead manufacturing operations on the production floor.
• Perform equipment setup, operation, and troubleshooting.
• Maintain machine uptime and perform fault clearing.
• Ensure all safety and compliance procedures are followed.
• Escalate concerns to management regarding safety, equipment functionality, product supply, or quality.
• Provide training to manufacturing staff on process and equipment.
• Collaborate with Quality, Engineering, and Manufacturing Support to resolve manufacturing events.
• Support Deviation Triage and Corrective and Preventive Actions (CAPA) processes.
• Write, review & revise controlled documentation (SOPs, Manufacturing Procedures, Forms, Technical Reports).
• Apply process, scientific, operational, and compliance knowledge to support manufacturing operations.
• Champion Lean Transformation and OE initiatives.
• Participate in the design, development, and implementation of processes.
• Collaborate with cross-functional teams.

Benefits

• Comprehensive employee benefits package including Retirement and Savings Plan with generous company contributions.
• Group medical, dental and vision coverage.
• Life and disability insurance.
• Flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED