Sr Engineer

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Letsdo this.

Letschange the world. In thisroleyou will provide technical leadership to Amgens 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,development and 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.

The Engineering professional weseekis a collaborative partner with these qualifications.

• DoctoratedegreeOR
• Master'sdegreeand2yearsofEngineeringexperienceOR
• Bachelor'sdegreeand4yearsofEngineeringexperienceOR
• Associate'sdegreeand8yearsofEngineeringexperienceOR
• High School Diploma /GEDand
  10yearsof
  
  Engineering experience.

• Advanceddegreeinengineering,biotechnology,lifesciencesorrelatedsubjectarea
• 2+years experience in the pharmaceutical or biotechnology industry that includes elementsofprocessdevelopment,process characterization,andtechnicaltransfersto manufacturing sites
• Advancedknowledgeofbiopharmaceuticalmanufacturingandbusinessprocesses,and experience supporting GMP manufacturing operations
• Knowledge of,andhands-onexperiencewithvariousdrugproducttechnologiesrelatedto fill-finishprocess(freeze-thaw,filtration,filling,isolators,visualinspectionoperationsetc.)
• Abilitytoleadinnovation,collaborateinamulti-functional team,andactondynamic information at a rapid pace
• Abilitytoindependentlydesignandcompletecharacterizationstudies,author characterizationprotocols,processtransferdocuments,andtechnicalreports
• Proficiencyintechnicalproblemsolving,critical thinking,andthedeliveryoftechnical solutions with limited oversight
• Capableoforganizingandcommunicatingtechnicalconceptstoenablebusinessdecisions
• Demonstratedskillsinleadingdiversemulti-functional projects

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, well 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,…