Sr Associate Manufacturing Bulk Drug Substance - Holly Springs, NC

Military Spouse Corporate Career Network•Holly Springs, NC

7d•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 facility expansion program and facility startup. This essential role will be part of a team responsible for manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill, 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.

Requirements

Manufacturing downstream purification operations including column packing, column chromatography, TFF, viral filtration, viral inactivation, conjugation, and final fill
Partnering across functions to ensure successful operational readiness, technology transfer, and ramp-up of manufacturing operations
Work outside standard business hours, including non-standard shifts, as needed to support startup, commissioning and qualification (C&Q), and engineering execution
Monday – Friday schedule from 8am – 5pm during startup phase
12-hour 2-2-3 schedule from 5:45 am to 6:15pm supporting 24/7 manufacturing operations
Ability to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime
Focus on operational readiness, training, and startup execution during early phases
Shift toward routine manufacturing execution and continuous improvement as facility transitions to steady state operations
cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR])
Strict adherence to safety and compliance
Initiate Quality observations (Discrepancies, Deviations, Testing Results Analysis (TRA), etc.)
Support or lead evaluations and investigations into quality observations
Interact with regulatory agencies as needed and guided
Proper gowning and aseptic techniques
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
Support readiness planning through execution of training, procedures, workflows, and operational practices
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment
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
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.)
Recognize and elevate problems during daily operations
Participate in the implementation of programs and CAPAs (Corrective Action Preventive Action)
Drive safety in all operations
Assist the manager in escalating concerns as needed
Maintain an organized, clean, and workable space
Draft and revise documents (SOPs, technical reports, and MPs)
Interact with management as an advisor in planning and in escalating potential concerns with the schedule and/or proce

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 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
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
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
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 proce