Specialist Manufacturing: Process Owner, Manufacturing Services 

HOW MIGHT YOU DEFY IMAGINATION?

You’veworked 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, experience,and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over10 million patientsworldwide. Come do your bestworkalongside other innovative, driven professionals in this meaningful role.

Be part of Amgen's 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 Amgen's plan to be a carbon-neutral company by 2027.

Specialist Manufacturing:Process Owner, Manufacturing Services

Live

What youwill do

Let’sdo this.Let’schange 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 ANC’s 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) team,Manufacturing, Process Development,Supply Chain,Facilities and Engineering,as 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

• Master’s degree in chemistry, biology,or engineering & 3 years of biotechnology operations experience or

• Bachelor’s degree and 5 years of biotechnology operations experience or

• Associate’s 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 (harvest,chromatography, filtration, bufferpreparation) and a broad understanding of related disciplinary areas in bioprocessing.

• Ability to organize,analyzeand interpret technical data through trend analysis, forecasting, modeling, etc.