Senior Associate Manufacturing

Responsibilities

• Perform manufacturing unit operations and manual visual inspection according to Standard Operating Procedures
• Manage characterization, data, and equipment within the drug product supply organization
• Support quality systems including Deviations, CAPA, LIMS, MES, SAP, and MAXIMO
• Execute process improvement projects and assist in new product introduction activities
• Perform data analysis of critical process parameters and identify process anomalies
• Conduct initial reviews of manufacturing procedures and batch records
• Provide process theory expertise and hands-on training to team members
• Maintain open communication between operations teams and escalate problems as needed

Requirements

• Master's degree OR Bachelor's degree + 6 months experience OR Associate's degree + 2 years experience OR High School Diploma + 4 years experience
• Experience in biotech/pharma manufacturing, laboratory, or manufacturing support roles
• Working knowledge of GMP regulations and the ability to interpret applicable regulations
• Strong technical writing skills and ability to perform computer operations (MES, SAP, etc.)
• Ability to work a flexible shift structure, which may include weekends or 24/7 operations

Preferred Qualifications

• Significant experience with manual visual inspection in a GMP regulated environment
• Experience with PAS X Werum software for electronic batch records
• Degree in Engineering, Chemistry, Biochemistry, Biology, or Computer Science
• Strong understanding of bioprocessing and drug product operations

Benefits

• Comprehensive medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program and stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to serving patients living with serious illnesses. Since 1980, we have pioneered advancements in oncology, inflammation, general medicine, and rare diseases to help people live longer, fuller, and happier lives.