Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness
- Employer
- Amgen
- Location
- Holly Springs, North Carolina
- Posted date
- Sep 28, 2026
View more categories
- Discipline
- Clinical, Marketing, Manufacturing & Production, Clinical Medicine, Product Development/Management, Manufacturing/Mechanical
- Required Education
- High School or equivalent
- Position Type
- Full time
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Job Details
HOW MIGHT YOU DEFY IMAGINATION?
Youveworked 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,experienceand passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds 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 New Product Introduction (NPI): Downstream Readiness
Live
What youwill do
Letsdo this.Letschange 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 ANCs Manufacturing Supportteam, this positionis responsibleforensuring new products are successfully introduced intoANCsbiologicsmanufacturingfacility.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.
Responsibilities:
New Product Introduction(NPI)leadcoordinatingwithManufacturing, Process Development,Supply Chain, Planning, Facilities and Engineering, Quality, and other teamsto introduce new Drug Substance products and/or advanced technologies into the plantusingproject management tools.
Technical expert who leads orparticipatesin projects, ensuring that production documents areaccurateand up to date.
Support Manufacturing in troubleshooting, problem-solvingand RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction(NPI)Change Controlsand collaborates with stakeholders 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 expectofyou
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
Associates degree & 8 years of biotechnology operations experience OR
Bachelors degree and 4 years of biotechnology operations experience OR
Masters 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 processingin Cell Culture or Purification(chromatography, filtration, buffer compounding) 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.
Background in lean manufacturing methodologies and operational excellence.
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.
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 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.
#AmgenNorthCarolina
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Phone
- 805-447-1000
- Location
- Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
