Join Amgenâs Mission of Serving Patients
At Amgen, if you feel likeyouârepart of something bigger,itâsbecause you are. Our shared missionâto serve patients living with serious illnessesâdrives all that we do.
Since 1980,weâvehelped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ we reach millions of patients each year. As a member of the Amgen team,youâllhelp 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 thatliewithin them,youâllthrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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 ManufacturingNew Product Introduction (NPI)
Live
What you will do
Letâsdo this.Letâschange the world.In this vital role you will communicate and interface between the GMP manufacturing teams in theAmgen North Carolina (ANC) Biologics Drug Substance ManufacturingplantandProcessDevelopment scientific groups. As part of ANCâs Manufacturing Supportteam, this positionis responsibleforensuring new products are successfully introduced intoANCâsbiologicsmanufacturingfacility. It is ahighly visible role across the site with the core responsibility ofhosting cross-functional meetings todrive totimelines to support the tech transfer of the program into the facility.This role will also offer the opportunity to propose,participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.Â
New Product Introduction lead coordinating withManufacturing, Process Development,Supply Chain, Planning, Facilities and Engineering,as well asQuality to introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools(i.e.Smartsheet).Â
Technical expert who leads orparticipatesin projects, ensuring that production documents areaccurateand up to date.
Support Manufacturing in troubleshooting, problemsolvingand RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction Change Controlsand collaborateswithstakeholders to drive on-time completion.  Respondsto regulatory questions and/or audit findings.
Champions Lean Transformation and OEinitiatives,facilitatesthe drive towards continuous improvement in the plant and tracks progress on a plant level.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. Themanufacturingprofessional weseekhas a biologics DSmanufacturing background withstrongcross-functional project managementandcommunicationskillsas well asthebelowqualifications.Â
Basic Qualifications:
High school diploma / GED & 10 years of biotechnology operations experience OR
Associateâs degree & 8 years of biotechnology operations experience OR
Bachelorâs degree and 4 years of biotechnology operations experience OR
Masterâs degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellentcross-functionalproject management, meeting facilitation, andtechnical writing skillsÂ
Experience in GMPmanufacturingoperations
Strong technical knowledge of drug substance processing (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing (cell culture, harvest)
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 writingforms
Ability to coach,mentorand/or cross train colleagues within core technical areas
Background in lean manufacturing methodologies and operational excellence
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 teammatesâ professional and personal growth
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