Senior Associate Manufacturing - Bulk Drug Substance Upstream - Days

What you will do

Let6sdo this!Let6schange the world! In this dynamic role, you will be a Sr Associate in the manufacturing organization at Amgen North Carolina (ANC).The essential position, which supports our critical 24/7 manufacturing operations,worksa 12-hour 2-2-3 schedule from 5:45am to 6:15pm.Associates will be executing operations on the floor in our upstreamareaandwillberesponsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

With general direction, the Senior Associate is responsible for executing on-the-floor operations within manufacturing in accordance with cGMP practices. As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.

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

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, F26E (Facilities 26 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

What we expect of you

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

Basic Qualifications:

• High School Diploma/GED + 4 years manufacturing and/or other regulated environment experience OR

• Associate6s Degree + 2 years manufacturing and/or other regulated environment experience OR

• Bachelor6s Degree + 6 months manufacturing and/or other regulated environment experience OR
• Master's Degree

Preferred Qualifications:

• Completion of NC BioWork Certificate Program

• Experience in biotechnology or pharmaceutical plant start up

• Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment

• Basic understanding of Upstream operation (Vial Thaw, Inoculation/Cell Expansion, Single Use Bioreactor, Production Bioreactor, ATF, Harvest Centrifuge, Depth Filtration)

• 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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we6ll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range