Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

BioSpace; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Amgen North Carolina is expanding its FleX Batch facility and seeking a Senior Associate Manufacturing - Bulk Drug Substance Upstream to join a cross-functional team.

You will support startup activities, readiness planning, and ramp-up of manufacturing operations as the site transitions to steady-state production.

Qualifications

• High School Diploma/GED with 4 years in manufacturing or other regulated environment.
• Associates Degree plus 2 years manufacturing or regulated experience.
• Bachelor's Degree plus 6 months manufacturing or regulated experience.
• Master's Degree in a related field preferred.

Responsibilities

• Support facility expansion and startup operations.
• Execute readiness tasks, equipment prep, and walkthroughs.
• Participate in commissioning, qualification, and startup activities.
• Provide operational feedback to ensure safe, compliant manufacturing.
• Collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams.

Skills

Manufacturing

cGMP

Quality systems

Education

High School Diploma/GED

Associates Degree

Bachelor's Degree

Master's Degree

Tools

EBR/MES

DeltaV

Electronic Quality Systems

Job description

Join Amgens Mission of Serving Patients

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

What you will do

Lets do this! Lets change the world! In this dynamic role, you will be anSenior Associate in the manufacturing organization at Amgen North Carolina (ANC) supporting the facility expansion program and facility startup. Thisessentialrole will be part of a team responsible for manufacturingcell cultureoperationsincluding seed train, SUBs, Perfusion, RTF, Stainless Steel BRXs, Depth Filtration and Centrifugation,while partnering across functions to ensure successful operational readiness, technology transfer, and rampup of manufacturing operations within the new facility. This role may require work outside standard business hours, including nonstandard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution. During this phase of thestartup, you will be expected toworkaMonday Friday schedule from 8am 5pm. As the business moves from C&Q to manufacturing operations, this essential positionwillwork ona 12-hour 2-2-3 schedule from 5:45 am to6:15pmsupporting 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-hourshift, 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 steadystate 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 rampup

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.

Basic Qualifications

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR
• Associates Degree + 2 years manufacturing and/or other regulated environment experience OR
• Bachelors Degree + 6 months manufacturing and/or other regulated environment experience OR
• Master's Degree

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, well 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.