Specialist Manufacturing New Product Introduction (NPI)
Specialist Manufacturing New Product Introduction (NPI)
US - North Carolina - Holly Springs Apply NowJoin Amgen’s Mission of Serving Patients
At Amgen, if you feel likeyou’repart of something bigger,it’sbecause you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980,we’vehelped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team,you’llhelp 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,you’llthrive 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
Let’sdo this.Let’schange 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 ANC’s Manufacturing Supportteam, this positionis responsibleforensuring new products are successfully introduced intoANC’sbiologicsmanufacturingfacility. 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.
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).
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.
Basic Qualifications:
High school diploma / GED & 10 years of biotechnology operations experience OR
Associate’s degree & 8 years of biotechnology operations experience OR
Bachelor’s degree and 4 years of biotechnology operations experience OR
Master’s 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 skills
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 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.
Applynowfor 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 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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