Specialist Manufacturing: Process Owner, Manufacturing Services
Specialist Manufacturing: Process Owner, Manufacturing Services
US - North Carolina - Holly Springs Apply NowHOW 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.
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 coach,mentorand/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 program,or 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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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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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