Senior Engineer

Let’sdo this.Let’schange the world. In thisroleyou will provide technical leadership to Amgen’s parenteral drug product process design and commercialization. The candidate will lead off-line process characterizationactivitiesandworkwithglobaltechnologytransferteamtotransfertheprocesstoclinical/commercialfillfinishlineswiththeaimofreducingoreliminatingtheonsitecharacterizationworkrequired. The candidate will also play a meaningful role in developing business cases for using the pilot plant capabilities further to serve the network, support developmentofsilico models to enable rapid, robust, process development.

• Operateandtroubleshootfillingequipmentforcharacterization,specialstudies, and/or material generation to support the Amgen network
• Design,implementanddocumenttechnicaldatapackagesrelatedtodrugproductprocess design,developmentand characterization
• Meticulousreviewofprotocols,andstudydesign,tostreamlineexecutionandensure successful implementation
• Supportdevelopmentofmodelsandotherdataanalyticstoolsforrapidprocess development and tech transfer
• Drive innovations in drug product process characterization and reduce pilot plant and clinical/commercialGMPlinetimerequiredforsuccessfultechnologytransfersandNPIs
• Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principlestoresolveissues,improveanddevelopnewprocessesandevaluateeffectsof equipment changes, scale, and implementation of new raw materials
• Serve as an authority on manufacturing technologies (e.g.filling, automated visual inspection)andworkwithglobalmulti-functionalteamstodevelopandimproveshared standard methodologies and technical advancements across Amgen clinical and commercial fill-finish plants
• Applystrongwrittenandverbalcommunicationalskills.Authortechnicalprotocols,reports and present findings and project status
• Contributetoandmaintainastrongcultureofsafetyandcomplianceintheplant
• Traveldomesticallyandinternationallymayberequired

Wearealldifferent,yetwealluseouruniquecontributionstoservepatients.TheEngineering professional weseekis a collaborative partner with these qualifications.

Basic Qualifications:

• DoctoratedegreeOR
• Master'sdegreeand2yearsofEngineeringexperienceOR
• Bachelor'sdegreeand4yearsofEngineeringexperienceOR
• Associate'sdegreeand8yearsofEngineeringexperienceOR
• HighSchoolDiploma/GEDand10yearsofEngineeringexperience.

Preferred Qualifications:

• Advanceddegreeinengineering,biotechnology,lifesciencesorrelatedsubjectarea
• 2+years experiencein the pharmaceutical or biotechnology industry that includes elementsofprocessdevelopment,processcharacterization,andtechnicaltransfersto manufacturing sites
• Advancedknowledgeofbiopharmaceuticalmanufacturingandbusinessprocesses,and experience supporting GMP manufacturing operations
• Knowledgeof,andhands-onexperiencewithvariousdrugproducttechnologiesrelatedto fill-finishprocess(freeze-thaw,filtration,filling,isolators,visualinspectionoperationsetc.)
• Abilitytoleadinnovation,collaborateinamulti-functionalteam,andactondynamic information at a rapid pace
• Abilitytoindependentlydesignandcompletecharacterizationstudies,author characterizationprotocols,processtransferdocuments,andtechnicalreports
• Proficiencyintechnicalproblemsolving,criticalthinking,andthedeliveryoftechnical solutions with limited oversight
• Capableoforganizingandcommunicatingtechnicalconceptstoenablebusinessdecisions
• Demonstratedskillsinleadingdiversemulti-functionalprojects

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, we’ll support your journey every step of the way.

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.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• A 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship for this role is not guaranteed.

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Salary Range