Manufacturing Associate, Bulk Drug Substance Upstream Days

HOWMIGHT YOU DEFY IMAGINATION

Youveworked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skillsexperienceand passion to work toward your goals At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies reaching over10 million patientsworldwide. Come do your best work alongside other innovative driven professionals in this meaningful role.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 Upstream - Days

Live

What you will do

Letsdo this!Letschange the world! In this dynamic role you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The scheduleisa rotating 2-2-35:45AM-6:15PM(12-hour shift).Associates will be completing operations on the floor inourupstreamareaandare responsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drugsubstance.

With general direction the Associate will support all floor operationsin accordance withcGMPpractices.

Responsibilities will include...

Compliance:

• Completes workin accordance withestablished 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 sanitizationmonitoringof equipment and assigned area

• Run andmonitorcritical process tasks per assigned procedures

• Perform in-process samplingoperateanalytical equipment and complete process documentation (Electronic Batch Records EBRs)

• Identifyand escalate issues and concernsregardingdaily 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 weseekare 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 NCBioWorksCertification 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 todemonstratedesire 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 Plancomprisinghealth 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

for a career that defies imagination

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

#AmgenNorthCarolina

Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation toparticipatein the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.