Senior Associate Manufacturing - Bulk Drug Substance Downstream - Days

Live 

What you will do 

Lets do this! Lets 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 manufacturingdownstream purification operations including column packing,columnchromatography, TFF,viralfiltration,viralinactivation, conjugation, and final fill,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 (C8Q), and engineering execution.During this phase of thestartup, you will be expected toworkaMonday 6 Friday schedule from 8am 6 5pm. As the business moves from C8Q 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.

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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The hard-working professional we seekis a team player with these qualifications.

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 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

• Understanding of downstream purification operation (Column Chromatography, TFF, Viral Filtration, Viral Inactivation)

• 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

Thrive