Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness

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 New Product Introduction (NPI): Downstream Readiness

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 ensuring new products are successfully introduced into ANC’s biologics manufacturing facility.  It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines 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) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality, and other teams to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools.  

• Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date. 

• Support Manufacturing in troubleshooting, problem-solving and RCAs. Support CAPA development to prevent error recurrence. 

• Owns New Product Introduction (NPI) Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings. 

• Champions Lean Transformation and OE initiatives, facilitates the 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. The manufacturing professional we seek has a biologics DS manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.  

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. 

• Excellent cross-functional project management, meeting facilitation, and technical writing skills. 

• Experience in GMP manufacturing operations. 

• Strong technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing. 

• Ability to organize, analyze and 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, mentor and/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 for field 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.  

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