Description
**HOW MIGHT YOU DEFY IMAGINATION?**
You’ve worked 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 over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen’s newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch 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 you** **will do**
Let’s do this. Let’s change 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 Manufacturing plant and Process Development scientific groups. As part of ANC’s Manufacturing Support team, this position is responsible for ownership of manufacturing services operations. It is a highly visible role across the site with the core responsibility of process ownership for manufacturing services unit operations which 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 expect** **of** **you**
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Downstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.
**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 expect** **of** **us**
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 Plan comprising 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 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.
**careers.amgen.com**
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 are provided reasonable accommodation to participate in 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.
**#AmgenNorthCarolina**
