Senior Associate Manufacturing Bulk Drug Substance Downstream Nights

HOW MIGHT 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 bestworkalongside 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.

Senior AssociateManufacturing-Bulk Drug Substance Downstream-Nights

Live

What youwill do

Letsdo this.Letschange the this dynamic roleyou will beaSenior Associate inthemanufacturing organization atAmgenNorth Carolina (ANC).The essential position which supports our critical 24/7 manufacturing operationsworksa 12-hour 2-2-3 schedule from 5:45pmto6:15a will beexecutingoperations on the floorin our downstreamareaandwillberesponsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.

With general direction the Senior Associateis responsible forexecuting on-the-floor operations within manufacturingin accordance withcGMP 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.

Responsibilitieswill 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

• Initiate quality non-conformance (NC) reports

• Interact with regulatory agencies asneeded andguided

• Assure proper gowning and aseptic techniques arealways followed

Process/Equipment/Facilities:

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

• Perform hands-ondownstream biotechoperations(Column Chromatography Tangential Flow Filtration Viral Filtration Viral Inactivation Column Packing among others)including set-upoperationcleaning sanitizationmonitoringof equipment and assigned area

• Runandmonitorcritical process tasksperassigned procedures

• Perform in-process samplingoperateanalytical equipment andcompleteprocess documentation(ElectronicBatchRecordsEBR)

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

• Initiate and own manufacturing relatedprocessdeviations

• Identify recommend and implement innovative process improvements and optimizations related to daily routine functions

• Assistin the review ofdocumentation for assigned functions (i.e.equipment logsEBRs)

• Collaborateas part of across-functional team (i.e.QA/QCF&E (Facilities & Engineering) PPICMfg.PD (Process Development) Regulatory etc.) in completing production activities

• Responsible forrecognizing andelevating 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 andassistthe 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 managementas an advisorin planningandinescalatingpotential concerns withtheschedule and/or process

Win

What we expectofyou

We are all different yet we all use our unique contributions to serve patients. The hard-working professional weseekis ateam player with these qualifications.

Basic Qualifications:

• HighSchoolDiploma/GED 4yearsmanufacturing and/orotherregulatedenvironmentexperience

Or

• AssociatesDegree 2 yearsmanufacturing and/orotherregulated environment experience

Or

• BachelorsDegree 6 monthsmanufacturing and/orotherregulatedenvironmentexperience

Or

• MastersDegree

Preferred Qualifications:

• Completion of NCBioWorksCertification Program

• Experience in biotechnology or pharmaceuticalplant start up

• Knowledge andprocessexperience within a cGMP manufacturingfacility or other highlyregulated 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

What you can expectofus

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