Senior Downstream Manufacturing Associate – Hybrid/Remote

NCBioImpact; Holly Springs (NC); Hybrid; USD 86,000 - 116,000; Full time

Benefits offered by this job

Flexible work model

Job summary

Amgen North Carolina (ANC) is seeking a Senior Associate in Downstream Manufacturing for the day shift, with possible work-from-home arrangements. The role focuses on on-the-floor cGMP manufacturing of drug substance in Manufacturing Services and requires collaboration with QA/QC, F&E, PPIC, and other teams to ensure compliance and high-quality output.

The initial schedule is Monday–Friday, 8-hour days, with potential transition to 12-hour day or night shifts as needed to meet business demands.

Qualifications

• Excellent verbal and written communication (technical) skills.
• Proficient Microsoft Office skills; knowledge of EBR/MES, Delta V, and Electronic Quality Systems.

Responsibilities

• Complete SOPs, MPs and CFR-aligned tasks with strict safety/compliance.
• Initiate deviation reports and interact with regulatory guidance as needed.
• Assist in review of equipment logs, EBRs and related docs.
• Collaborate with QA/QC, Facilities & Engineering, PPIC, Mfg., PD and Regulatory on production activities.
• Drive safety, identify issues, and contribute to CAPAs for continuous improvements.

Skills

Excellent verbal and written comms (te

Education

High School Diploma/GED

Associate’s Degree

Bachelor’s Degree

Master’s Degree

Tools

DeltaV

MS Office

Electronic Quality Systems

EBR/MES

Job description

Amgen North Carolina (ANC) is seeking a Senior Associate in Downstream Manufacturing for the day shift, with possible work-from-home arrangements. The role focuses on on-the-floor cGMP manufacturing of drug substance in Manufacturing Services and requires collaboration with QA/QC, F&E, PPIC, and other teams to ensure compliance and high-quality output.

The initial schedule is Monday–Friday, 8-hour days, with potential transition to 12-hour day or night shifts as needed to meet business demands.