Upstream Biologics Manufacturing Senior Associate

Amgen Inc. (IR); Holly Springs (NC); On-site; USD 86,000 - 116,000; Full time

Job summary

Amgen North Carolina is seeking a Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days to support the facility expansion and startup. You will be part of a team handling seed train, SUBs, Perfusion, RTF, and related upstream operations, coordinating with QA/QC, F&E, PPIC, Mfg., PD, and Regulatory.

The role requires flexibility for shifts and startup phases, with a focus on operational readiness, training, and transitioning to steady-state production, while contributing to

Qualifications

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience.
• Associate’s Degree + 2 years manufacturing and/or other regulated environment experience.
• Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience.
• Master’s Degree.
• Completion of NC BioWork Certificate Program.
• Experience in biotechnology or pharmaceutical plant start up.
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
• Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration).
• 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.

Responsibilities

• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment of 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 [EBR]).
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities.
• Identify, recommend, and implement innovative process improvements and optimizations related to daily routine functions.
• Assist in the review of documentation for assigned functions (i.e., equipment logs, EBRs, ESPs).
• Collaborate cross-functionally (i.e., QA/QC, F&E (Facilities & Engineering), PPIC (Production Planning and Inventory Control), Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.
• Responsible for recognizing and elevating problems during daily operations.
• Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action) with an eye toward continuous improvement.
• Drive safety in all operations, and assist the manager in escalating concerns as needed.
• Maintain an organized, clean, and workable space.
• Draft and revise documents (SOPs, technical reports, and MPs).
• Interacts with management as an advisor in planning and in escalating potential concerns with the schedule and/or process.

Skills

Communication skills

Verbal & written communication

Microsoft Office

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Amgen North Carolina is seeking a Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days to support the facility expansion and startup. You will be part of a team handling seed train, SUBs, Perfusion, RTF, and related upstream operations, coordinating with QA/QC, F&E, PPIC, Mfg., PD, and Regulatory.

The role requires flexibility for shifts and startup phases, with a focus on operational readiness, training, and transitioning to steady-state production, while contributing to