Associate Manufacturing - Bulk Drug Substance Downstream - Days

About the role

In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm. Associates will be completing operations on the floor in our downstream area and will be responsible for the manufacturing of cGMP drug substances. With general direction, the Associate will support all floor operations in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance
• Assure proper gowning and aseptic techniques are always followed
• Perform hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area
• Run and monitor critical process tasks per assigned procedures
• Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records)
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities
• Initiate and own manufacturing related process deviations
• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
• Perform documentation for assigned functions (i.e., equipment logs, EBRs)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities
• Maintain an organized, clean, and workable space

Basic Qualifications

• High School/GED + 2 years manufacturing and/or other regulated environment experience
• Or Associates Degree + 6 months manufacturing and/or other regulated environment experience
• Or Bachelors Degree

Preferred Qualifications

• Completion of NCBioWorks Certification Program
• Experience in a regulated industry such as biotechnology or pharmaceutical
• Basic understanding and process experience in a cGMP manufacturing facility
• Excellent verbal and written communication
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

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
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible