Senior Associate Manufacturing

About the role

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. As a Senior Associate Manufacturing in the Drug Product Supply organization at our Thousand Oaks site, you will support the manual visual inspection team and contribute to process improvement, quality systems, new product introduction, and production operations.

Responsibilities

• Perform manufacturing unit operations according to Standard Operating Procedures with minimal supervision.
• Schedule operations for multiple functional areas.
• Understand process parameters and identify process anomalies.
• Perform data analysis of critical process parameters.
• Operate complex critical processing equipment.
• Assist in planning and implementing continuous improvement solutions.
• Ensure operations are completed per manufacturing schedule, including delegation of tasks.
• Serve as the primary resource for processing operations on the manufacturing floor.
• Identify and propose solutions to complex problems.
• Resolve problems during operations.
• Perform initial review of manufacturing procedures and batch records.
• Review, revise, and audit documents.
• Perform computer operations (MES, EBR, MAXIMO, LIMS, and SAP).
• Provide process theory expertise and hands-on training to others.
• Own deviations/CAPA or provide suggestions for corrective and preventive actions.
• Apply research, information gathering, and interpretation skills to diverse problems.
• Utilize project management skills to set timelines and priorities.
• Recognize and escalate problems.
• Establish working relationships outside your area of expertise.
• Support flexible shift structure, including 24/7 or weekend operations as needed.
• Apply basic chemistry, biology, and physical principles relevant to the position.
• Demonstrate organizational skills and high attention to detail.
• Exhibit strong written and oral communication skills, including technical writing.
• Interpret and apply GMP regulations.

Qualifications

Basic Qualifications

• Master’s degree, or
• Bachelor’s degree and 6 months of experience in biotech/pharma manufacturing, laboratory, or manufacturing support (e.g., laboratories, engineering, facilities, quality), or
• Associate’s degree and 2 years of experience in biotech/pharma manufacturing, laboratory, or manufacturing support, or
• High School Diploma/GED and 4 years of experience in biotech/pharma manufacturing, laboratory, or manufacturing support.

Preferred Qualifications

• Prior experience with lab equipment, computers, and intermediate mathematical skills.
• Significant experience with manual visual inspection in a GMP-regulated environment.
• Experience with PAS X Werum software for electronic batch records, including editing and validation.
• Degree in Engineering, Chemistry, Biochemistry, Biology, or Computer Science with biotechnology experience.
• Demonstrated technical writing skills.
• Strong knowledge of manual visual inspection or related bioprocessing areas (Drug Product operations).
• Demonstrated ability to work in a team environment.

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted on the careers site. Actual salary will vary based on relevant skills, experience, and qualifications.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions.
• Group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives).
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.