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Specialist Manufacturing New Product Introduction (NPI): Upstream Readiness

Amgen

Holly Springs, NC, USonsite

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About this role

Career Category Manufacturing Job 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 New Product Introduction (NPI): Upstream 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   P rocess   D evelopment scientific groups.   As part of ANC’s Manufacturing Support   team , this position   is responsible   for   ensuring new products are successfully introduced into   ANC’s   b iologics   manufacturing   fa cility .    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   communicat ion   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 the

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