Senior Associate - Bulk Drug Substance Manufacturing Services - Days

BioSpace; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

Amgen in North Carolina is seeking a Senior Associate in Bulk Drug Substance Manufacturing Services (Days). You will support the ANC2 facility startup, oversee weigh/dispense, material handling, and preparation of media, buffers, and solutions.

The role includes training staff and ensuring safe, compliant operations. During startup, you will collaborate with QA/QC, Facilities & Engineering, PPIC, and Regulatory teams, advancing operational readiness and continuous improvement as the facility

Qualifications

• Experience working in cGMP manufacturing environments.
• Ability to support startup, qualification, and commissioning activities.
• Strong collaboration with QA/QC, E&F, PPIC and regulatory teams.

Responsibilities

• Support services operations including weigh/dispense of raw materials and handling of materials.
• Assist with media, buffer, and solution preparation and component prep activities.
• Coordinate daily activities, train staff, and promote safe, compliant execution.
• Assist in equipment startup, calibration, and qualification tasks during startup.
• Contribute to continuous improvement and CAPA programs.

Skills

Weigh & dispense

Material handling

Media prep

Buffer prep

Solution prep

Autoclave ops

Equipment setup

Process improvement

Staff training

cGMP compliance

Job description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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 - Bulk Drug Substance Manufacturing Services - Days

Live

What you will do

Lets do this. Lets change the world! In this dynamic role, you will be a Senior Associate in the Manufacturing organization at Amgen North Carolina (ANC), supporting the ANC2 facility expansion and startup program. This essential role will be part of the Services team responsible for enabling manufacturing operations through weigh and dispense of raw materials, material receiving and handling, media, buffer, and solution preparation, and component preparation activities, including parts washing and autoclave operations.

As a Senior Associate, you will provide technical and operational support to the Services area, help coordinate daily activities, support training and qualification of staff, and promote safe, compliant, and reliable execution. You will partner across functions to support successful operational readiness, technology transfer, facility startup, and the 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 startup, you will be expected to work a Monday through Friday schedule from 8:00 a.m. to 5:00 p.m. As the business transitions from C&Q to manufacturing operations, this essential position will move to a 12-hour, 2-2-3 schedule from 5:45 a.m. to 6:15 p.m., supporting critical 24/7 manufacturing operations.

Because Amgen relies on the regular attendance of all staff members to meet legitimate business needs, individuals in this role must be able to work their assigned 12-hour shift, including during inclement weather, on some holidays, and during requested overtime in support of operations.

During the early phases of the project, this role will focus on operational readiness, training, procedure development, equipment and process familiarization, startup execution, and coordination of Services activities. As the facility transitions to steady-state operations, the role will shift toward routine manufacturing execution, oversight of daily floor activities, troubleshooting, coaching and development of staff, cGMP documentation, and continuous improvement.

With general direction, the Senior Associate will support and help lead Services floor operations in accordance with current Good Manufacturing Practices (cGMP), applicable procedures, safety requirements, and established production schedules.

Responsibilities will include

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 deviation reports
• Interact with regulatory agencies as needed and guided
• Assure proper gowning and aseptic techniques are always followed

Process/Equipment/Facilities

• Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and 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)
• Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, 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)