Specialist Manufacturing Process Owner, Manufacturing Services

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 skills experienceand 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.

Specialist Manufacturing:Process Owner Manufacturing Services

Live

What youwill do

Letsdo this.Letschange the world.In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance ManufacturingplantandProcessDevelopment scientific groups.As part of ANCs Manufacturing Supportteam this positionis responsibleforownership ofmanufacturing servicesoperations.It is ahighly visible role across the site with the core responsibilityofprocess ownership formanufacturingservicesunit operationswhich includes media preparation buffer preparation and manufacturing material kitting and transportation.

Responsibilities:

• Manufacturing servicestechnicalexpertwho leadsweigh and dispensing operations media and buffer solution prepsandparticipatesin projects including aidingincommissioning and qualification and training staff onsingle-use technology analyticalequipmentand processes.

• Coordinating withNew Product Introduction (NPI) teamManufacturing Process DevelopmentSupply ChainFacilities and Engineeringas well asQuality to introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools(i.e.Smartsheet).

• Support Manufacturing in troubleshooting problemsolvingandparticipatingindeviationRCAs.Own andCAPAand Change Controlstoprevent error recurrenceand continuous improvement.

• Ensurethatmanufacturingproductiondocuments(e.g.Standard Operating Procedures)areaccurateandalignwith electronic batch records.

• Lead tabletop and waterrunsto test recordsand SOP updatesprior to usebefore major changes.

• Providehypercaresupport during first batch runs PPQs and/or during implementation ofnew technologies.

Win

What we expectofyou

We are all different yet we all use our unique contributions to serve patients. Themanufacturingprofessional weseekhas a biologicsDrug SubstanceDownstreammanufacturing background withstrongcross-functional project managementandcommunicationskillsas well asthebelowqualifications.

Basic Qualifications:

• Doctorate degree OR

• Masters degree in chemistry biologyor engineering & 3 years of biotechnology operations experience or

• Bachelors degree and 5 years of biotechnology operations experience or

• Associates degree & 10 years of biotechnology operations experience or

• High school diploma / GED & 12 years of biotechnology operations experience

Preferred Qualifications:

• Degree in Chemical Engineering Industrial Engineering Biology or Biochemistry

• Excellentcross-functionalproject management meeting facilitation andtechnical writing skills

• Experience inDownstreamGMPmanufacturingoperations

• Strong technical knowledge of drug substance processing (harvestchromatography filtration bufferpreparation) and a broad understanding of related disciplinary areas in bioprocessing.

• Ability to organizeanalyzeand interpret technical data through trend analysis forecasting modeling etc.

• Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms

• Ability to coachmentorand/or cross train colleagues within core technical areas

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 annual base salary range for this opportunity in the U.S. is provided below.

In addition to the base salary 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 programor forfield 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.

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 areprovidedreasonable 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.

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