Senior Associate Manufacturing - Continuous Improvement Lead

About the role

The Senior Associate Manufacturing - Continuous Improvement Lead will support the start-up of the Amgen North Carolina (ANC) manufacturing facility. During start-up, the CI Lead will oversee operational readiness activities in various manufacturing areas such as Dispensing, Buffer/Media Preparation, Upstream Cell Culture, Harvest, Downstream Purification, Analytical Testing, or Column Packing. They will support SOP creation, review, and approval; equipment and supplies specification, design of job aids and work instructions, digital tool advancement, and staff training.

Responsibilities

• Provide technical support and subject matter expertise for manufacturing areas.
• Oversee support and ongoing development of all manufacturing systems including SOP, TRNQ, MES, QMS records, among others.
• Train staff (associates, operators, technical/QA/support) on assigned manufacturing systems.
• Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility.
• Facilitate process, area, and equipment quality risk assessments as needed to identify risks, failure modes, and mitigating actions.
• Manage the CI program when the plant is in production, which includes conducting time studies to identify process inefficiencies, leading improvement projects in designated MFG area (i.e. upstream, downstream, solution prep), implementing proper change management, and tracking sustainment of implemented changes.
• Lead cross-functional CAPAs and EVs as required.
• Lead learning team meetings and kaizen events.
• Lead cross-functional CAPAs and EVs as required.

Requirements

• High school diploma/GED and 4 years of Manufacturing or Operations experience OR
• Associates degree and 2 years of Manufacturing or Operations experience OR
• Bachelors degree and 6 months of Manufacturing or Operations experience OR
• Masters degree

Preferred Qualifications

• Education in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering
• Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing
• Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff
• Ability to lead small and large cross-functional meetings efficiently
• Knowledge of process improvement or lean fundamentals
• Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality

Benefits

Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. These plans include:

• Base Salary
• Health Insurance
• Retirement Savings Plan
• Flexible Spending Accounts
• Employee Assistance Programs
• Wellness Programs
• Professional Development Opportunities
• Work-Life Balance Initiatives

Pay

Details about pay will be provided upon hire.

Schedule

Details about the schedule will be provided upon hire.