Sr Associate Manufacturing Bulk Drug Substance - Holly Springs, NC

ATTENTION MILITARY AFFILIATED JOB SEEKERS
- Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

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. Thisessentialrole 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 toworka

Monday – 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 steady state operations, the role will shift toward routine manufacturing execution and continuous improvement.

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 [E ])

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…