Manufacturing Associate Bulk Drug Substance Manufacturing Services Days

Join Amgens Mission of Serving Patients

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Manufacturing Associate - Bulk Drug Substance Manufacturing Services - Days

Live

What you will do

Lets do this. Lets change the world! In this dynamic role you will be an 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. You will also 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 and startup execution. As the facility transitions to steady-state operations the role will shift toward routine manufacturing execution reliable delivery of materials and prepared solutions equipment operation cGMP documentation and continuous improvement.

With general direction the Associate will support Services floor operations in accordance with current Good Manufacturing Practices (cGMP) applicable procedures safety requirements and established production schedules.

Responsibilities will include...

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

• Assure proper gowning and aseptic techniques are always followed

Process/Equipment/Facilities:

• Perform hands-on operations including set-up cleaning sanitization monitoring of equipment in assigned area

• Run and monitor critical process tasks per assigned procedures

• Buffer and Media preparation and transfer

• Weigh and dispense of materials to be used in the preparation of Buffers and Medias

• Perform in-process sampling operate analytical equipment and complete process documentation (Electronic Batch Records EBRs)

• Complete washroom activities: cleaning equipment small to large scale used in production activities

• Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions

• Perform 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

• Maintain an organized clean and workable space

Win

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.

Basic Qualifications:

• High School/GED 2 years manufacturing and/or other regulated environment experience

Or

• Associates Degree 6 months manufacturing and/or other regulated environment experience

Or

• Bachelors Degree

Preferred Qualifications:

• Completion of NC BioWork Certificate Program

• Experience in a regulated industry such as biotechnology or pharmaceutical

• Basic understanding and process experience in a cGMP manufacturing facility

• Excellent verbal and written communication

• Proficient Microsoft Office skills and knowledge of other electronic systems such as EBR/MES Delta V and Electronic Quality Systems

• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

Thrive

What you can expect of us

As we work to develop treatments that take care of others we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities including:

• 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

• No relocation assistance will be provided for these positions

for a career that defies imagination

Objects in your future are closer than they appear. Join us.