Senior Associate, Manufacturing

This Senior Associate Manufacturing position will coordinate and lead production operations on the manufacturing floor including taking a lead role in the qualification of process equipment, supporting development, clinical, and launch activities. This role is a key communication and technical interface between the GMP manufacturing teams in the plant and our partner organizations.

The initial focus of this role will be part of the AR30 startup team on Admin Day shift to prepare the facility for Operational Readiness. This includes and not limited to support interviewing of manufacturing operations team, develop training, SOPs, electronic batch records, job hazards analysis, and standard work. Participate in Factory acceptance test and also commissioning and qualification of process equipment.

After the facility startup phase (up to one year), the successful incumbent will be expected to join a night shift team working a 12-hour shift. The shift pattern will be a 7PM - 7AM structure with a rotation covering 7 nights per week. The rotating 12-hour night shift offers several benefits, with an average of 14 days on shift per month with every other weekend off. In addition, the night shift is eligible for a shift differential and any Sundays worked receive Premium pay.

There are multiple openings for this position.

Responsibilities:

• Lead manufacturing operations on the production floor.
• Ensure all safety and compliance procedures are followed at all times.
• Participate in the development, execution, and issue resolution associated with process equipment Commissioning, Qualification and Validation.
• Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor.
• Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.)
• Serve as SME for Cell Culture operations.
• Provide training to manufacturing staff on process and equipment.
• Own Non-Conformances (NC) and Corrective and Preventive Actions (CAPA) Champion Lean Transformation and OE initiatives, facilitate the drive towards continuous improvement in all Manufacturing areas.
• Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner.
• Assure appropriate escalation to various levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk.
• Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development and Regulatory Compliance staff in cross-functional teams.
• Participate in the design, development, and implementation of processes in support of the manufacturing floor.

Basic Qualifications:

• Master's degree
• OR
• Bachelor's degree and 2 years of Manufacturing or Operations experience
• OR
• Associate's degree and 6 years of Manufacturing or Operations experience
• OR
• High school diploma / GED and 8 years of Manufacturing or Operations experience

Preferred Qualifications:

• Bachelor's degree in Science or Engineering
• Knowledge of cell culture operations and bioreactors
• Knowledge of analytical equipment and computers
• CFR and Regulatory knowledge
• Mechanical aptitude with ability and expertise
• Independently collaborate with outside resources
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Troubleshooting skills on process equipment
• Ability to lead teams

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.