Career CategoryManufacturing
Job DescriptionSenior Associate Manufacturing - Bulk Drug Substance Upstream - Days What you will do Let's do this! Let's change the world! In this dynamic role, you will be an Senior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. This essential role will be part of a team responsible for manufacturing cell culture operations including seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation, while partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations within the new facility.
This role may require work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of the startup, you will be expected to work a Monday - Friday schedule from 8am - 5pm. As the business moves from C&Q to manufacturing operations, this essential position will work on a 12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting our critical 24/7 manufacturing operations. As Amgen relies upon the regular attendance of all staff members to meet legitimate business needs, this role must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our operations.
During early phases, this role will focus on operational readiness, training, and startup execution. As the facility transitions to steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.
Compliance: - Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
- Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.) as well as support or lead evaluations and investigations into quality observations
- Interact with regulatory agencies as needed and guided
- Assure proper gowning and aseptic techniques are always followed
Operational Readiness & Facility Startup - Support operational readiness activities for facility expansion and startup
- Execute manufacturing readiness tasks including equipment preparation, procedure execution, and process walkthroughs
- Participate in commissioning, qualification, and startup activities as trained and assigned
- Provide operational feedback during startup activities to support safe, compliant, and efficient manufacturing
- Support readiness planning through execution of training, procedures, workflows, and operational practices required for startup and ramp-up
Process/Equipment/Facilities: - 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
Administrative: - 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
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seek is a team player with these qualifications.
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
Preferred Qualifications: - 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
What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Salary Range86,048.05USD -116,417.95 USD
