Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days
Amgen
August 07, 2026
On-site
Holly Springs, NC
Operations
Senior Associate Manufacturing – Bulk Drug Substance Downstream – Days
Responsibilities:
- Execute on-the-floor cGMP manufacturing operations supporting critical 24/7 operations on a 12-hour 2-2-3 schedule (5:45am–6:15pm).
- Complete work per SOPs/MPs/JHAs and CFR; follow safety and compliance requirements.
- Initiate quality non-conformance (NC) reports; ensure proper gowning and aseptic techniques.
- Support regulatory interactions as guided.
- Perform downstream purification and biotech operations (Column Chromatography, TFF, Viral Filtration/Inactivation, Column Packing): setup, operation, cleaning/sanitization, monitoring equipment/areas.
- Run and monitor critical process tasks; perform in-process sampling and operate analytical equipment.
- Complete process documentation (Electronic Batch Records/EBR).
- Perform washroom activities (cleaning equipment at small to large scale).
- Initiate and own process deviations; drive process improvements.
- Assist with documentation review (equipment logs/EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory); recognize/escalate problems.
- Participate in CAPAs and continuous improvement; maintain organized/clean workspace; draft/revise SOPs/technical reports/MPs.
Qualifications:
- High School Diploma/GED + 4 years manufacturing/regulated environment OR Associate’s + 2 years OR Bachelor’s + 6 months OR Master’s.
Preferred Skills/Experience:
- NC BioWorks certification; biotech/pharma plant start-up experience.
- cGMP (highly regulated) experience; downstream understanding (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
- Technical verbal/written communication.
- Microsoft Office; experience with EBR/MES, DeltaV, Electronic Quality Systems.
Benefits:
- Total Rewards Plans (competitive and comprehensive) aligned with local industry standards.
Application Instructions:
- Apply at careers.amgen.com.
Responsibilities:
- Execute on-the-floor cGMP manufacturing operations supporting critical 24/7 operations on a 12-hour 2-2-3 schedule (5:45am–6:15pm).
- Complete work per SOPs/MPs/JHAs and CFR; follow safety and compliance requirements.
- Initiate quality non-conformance (NC) reports; ensure proper gowning and aseptic techniques.
- Support regulatory interactions as guided.
- Perform downstream purification and biotech operations (Column Chromatography, TFF, Viral Filtration/Inactivation, Column Packing): setup, operation, cleaning/sanitization, monitoring equipment/areas.
- Run and monitor critical process tasks; perform in-process sampling and operate analytical equipment.
- Complete process documentation (Electronic Batch Records/EBR).
- Perform washroom activities (cleaning equipment at small to large scale).
- Initiate and own process deviations; drive process improvements.
- Assist with documentation review (equipment logs/EBRs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Mfg., PD, Regulatory); recognize/escalate problems.
- Participate in CAPAs and continuous improvement; maintain organized/clean workspace; draft/revise SOPs/technical reports/MPs.
Qualifications:
- High School Diploma/GED + 4 years manufacturing/regulated environment OR Associate’s + 2 years OR Bachelor’s + 6 months OR Master’s.
Preferred Skills/Experience:
- NC BioWorks certification; biotech/pharma plant start-up experience.
- cGMP (highly regulated) experience; downstream understanding (Column Chromatography, TFF, Viral Filtration, Viral Inactivation).
- Technical verbal/written communication.
- Microsoft Office; experience with EBR/MES, DeltaV, Electronic Quality Systems.
Benefits:
- Total Rewards Plans (competitive and comprehensive) aligned with local industry standards.
Application Instructions:
- Apply at careers.amgen.com.