Senior Associate Bulk Drug Substance Manufact - Holly Springs, NC

Military Spouse Corporate Career Network • Holly Springs, NC

1d • Onsite

About The Position

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.

Requirements

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience
• Associate’s Degree + 2 years manufacturing and/or other regulated environment experience
• Bachelor’s Degree + 6 months manufacturing and/or other regulated environment experience
• Master's Degree
• Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems

Nice To Haves

• Completion of NC BioWorks Certification Program
• Experience in biotechnology or pharmaceutical plant start up
• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
• Strong understanding of solution preparation, equipment preparation, and inventory control operations
• Excellent verbal and written communication (technical) skills

Responsibilities

• 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
• 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) 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
• 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

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: High school or GED