Senior Associate Manufacturing - Downstream - Nights

Role Summary

Senior Associate Manufacturing - Downstream - Nights at Amgen North Carolina (ANC). This role supports 24/7 downstream manufacturing operations and is responsible for manufacturing cGMP drug substances on a 12-hour 2-2-3 shift from 5:45pm to 6:15am. The role works under general direction on-the-floor, ensuring safe, compliant, and efficient production as part of Amgen's drug substance manufacturing program.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Initiates quality non-conformance (NC) reports.
• Interacts with regulatory agencies as needed and guided.
• Ensures proper gowning and aseptic techniques are always followed.
• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
• Performs hands-on downstream biotech operations (Column Chromatography, Tangential Flow Filtration, Viral Filtration, Viral Inactivation, Column Packing, among others) including setup, operation, cleaning, sanitization, and monitoring of equipment and assigned area.
• Runs and monitors critical process tasks per assigned procedures.
• Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBR]).
• Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
• Initiates and owns manufacturing-related process deviations.
• Identifies, recommends, and implements innovative process improvements and optimizations related to daily routine functions.
• Assists in the review of documentation for assigned functions (e.g., equipment logs, EBRs).
• Collaborates as part of a cross-functional team (QA/QC, F&E, PPIC, Mfg., PD, Regulatory, etc.) in completing production activities.
• Recognizes and elevates problems during daily operations.
• Participates in the implementation of programs and CAPAs with a focus on continuous improvement.
• Drives safety in all operations and escalates concerns as needed.
• Maintains an organized, clean, and workable space.

Administrative

• Drafts and revises documents (SOPs, technical reports, and MPs).
• Interacts with management as an advisor in planning and escalating potential concerns with the schedule and/or process.

Qualifications

• Required: High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
• Required: Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR
• Required: Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR
• Required: Master’s Degree
• Preferred: Completion of NC BioWorks Certification Program
• Preferred: Experience in biotechnology or pharmaceutical plant startup
• Preferred: Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Preferred: Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)

Skills

• Excellent verbal and written communication (technical) skills
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Additional Requirements

• Must be able to work a 12-hour shift (5:45pm–6:15am) on a 2-2-3 schedule to support 24/7 operations; includes potential inclement weather, some holidays, and overtime