Senior Associate Manufacturing, Upstream - Days (Multiple Positions)
Amgen
4 months ago
On-site
Holly Springs, NC
Operations
Senior Associate Manufacturing, Upstream (Days)
What You Will Do
- Execute on-the-floor upstream manufacturing operations in accordance with cGMP practices for manufacturing cGMP drug substances.
- Support critical 24/7 manufacturing operations on a 12-hour 2-2-3 schedule from 5:45am to 6:15pm (including inclement weather, some holidays, and requested overtime).
Compliance
- Complete work per established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict safety and compliance adherence.
- Initiate quality observations (discrepancies, deviations, Testing Results Analysis, etc.) and support/lead evaluations and investigations into quality observations.
- Interact with regulatory agencies as needed and guided.
- Assure proper gowning and aseptic techniques are always followed.
Process/Equipment/Facilities
- Perform hands-on operations: set-up, cleaning, sanitization, and monitor equipment for 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 at small to large scale).
- Identify, recommend, and implement innovative process improvements/optimizations.
- Assist in review of documentation (equipment logs, EBRs, ESPs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Manufacturing, PD, Regulatory, etc.).
- Recognize and elevate problems during daily operations.
- Participate in programs and CAPAs (Corrective Action/Preventive Action) for continuous improvement.
- Drive safety and assist manager in escalating concerns.
- Maintain an organized, clean, workable workspace.
Administrative
- Draft and revise documents (SOPs, technical reports, MPs).
- Advise management on planning and escalating potential schedule/process concerns.
Basic Qualifications
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
- Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR
- Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR
- Master’s Degree.
Preferred Qualifications / Skills
- Completion of NC BioWork Certificate Program.
- Experience in biotechnology or pharmaceutical plant start up.
- Knowledge/process experience in a cGMP manufacturing facility or other highly regulated environment.
- Basic understanding of upstream operations (vial thaw, inoculation/cell expansion, single-use bioreactor, production bioreactor, ATF, harvest centrifuge, depth filtration).
- Excellent technical verbal and written communication.
- Proficient Microsoft Office skills; knowledge of electronic systems (EBR/MES, Delta V, Electronic Quality Systems).
Benefits (explicitly stated)
- Total Rewards Plans (competitive and comprehensive) in addition to base salary.
Application Instructions
- Apply now via careers.amgen.com.
What You Will Do
- Execute on-the-floor upstream manufacturing operations in accordance with cGMP practices for manufacturing cGMP drug substances.
- Support critical 24/7 manufacturing operations on a 12-hour 2-2-3 schedule from 5:45am to 6:15pm (including inclement weather, some holidays, and requested overtime).
Compliance
- Complete work per established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict safety and compliance adherence.
- Initiate quality observations (discrepancies, deviations, Testing Results Analysis, etc.) and support/lead evaluations and investigations into quality observations.
- Interact with regulatory agencies as needed and guided.
- Assure proper gowning and aseptic techniques are always followed.
Process/Equipment/Facilities
- Perform hands-on operations: set-up, cleaning, sanitization, and monitor equipment for 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 at small to large scale).
- Identify, recommend, and implement innovative process improvements/optimizations.
- Assist in review of documentation (equipment logs, EBRs, ESPs).
- Collaborate cross-functionally (QA/QC, F&E, PPIC, Manufacturing, PD, Regulatory, etc.).
- Recognize and elevate problems during daily operations.
- Participate in programs and CAPAs (Corrective Action/Preventive Action) for continuous improvement.
- Drive safety and assist manager in escalating concerns.
- Maintain an organized, clean, workable workspace.
Administrative
- Draft and revise documents (SOPs, technical reports, MPs).
- Advise management on planning and escalating potential schedule/process concerns.
Basic Qualifications
- High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
- Associate’s Degree + 2 years manufacturing and/or other regulated environment experience OR
- Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience OR
- Master’s Degree.
Preferred Qualifications / Skills
- Completion of NC BioWork Certificate Program.
- Experience in biotechnology or pharmaceutical plant start up.
- Knowledge/process experience in a cGMP manufacturing facility or other highly regulated environment.
- Basic understanding of upstream operations (vial thaw, inoculation/cell expansion, single-use bioreactor, production bioreactor, ATF, harvest centrifuge, depth filtration).
- Excellent technical verbal and written communication.
- Proficient Microsoft Office skills; knowledge of electronic systems (EBR/MES, Delta V, Electronic Quality Systems).
Benefits (explicitly stated)
- Total Rewards Plans (competitive and comprehensive) in addition to base salary.
Application Instructions
- Apply now via careers.amgen.com.