Sr Engineer

BioSpace; Thousand Oaks (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Amgen is seeking a Senior Engineer to provide technical leadership in parenteral drug product process design and commercialization. You will lead offline characterization activities and collaborate with global technology transfer teams to transfer processes to clinical/commercial fill-finish lines, aiming to reduce onsite characterization work.

The role involves developing business cases for pilot plant capabilities, supporting development of computational models, and enabling rapid, robust

Qualifications

• Doctorate degree or
• Master's degree and 2 years of engineering experience or
• Bachelor's degree and 4 years of engineering experience or
• Associate's degree and 8 years of engineering experience or
• High School Diploma/GED and 10 years of engineering experience.

Responsibilities

• Operate and troubleshoot filling equipment for characterization, studies, and material generation to support the Amgen network.
• Design, implement and document technical data packages related to drug product process design, development and characterization.
• Meticulous review of protocols and study design to streamline execution and ensure successful implementation.
• Support development of models and other data analytics tools for rapid process development and tech transfer.
• Drive innovations in drug product process characterization and reduce pilot plant and GMP line time for successful technology transfers and NPIs.

Skills

Process characterization

Biopharmaceuticals

Scale-up

Problem solving

Technical leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High School Diploma/GED

Job description

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 illnessesdrives 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.

Senior Engineer

What You Will Do

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,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

What we expect of you

Basic Qualifications

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

What you can expect of us

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, 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