Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness

BioSpace; Holly Springs (NC); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Comprehensive benefits package

Discretionary annual bonus

Stock-based long-term incentives

Time-off and flexible work models

Job summary

Amgen North Carolina Biologics Drug Substance Manufacturing plant is seeking a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to drive successful tech transfers and NPI changes. You will lead cross-functional meetings with Manufacturing, Process Development, Supply Chain, Planning, Facilities, Engineering and Quality to introduce new drug substances into the facility.

The role emphasizes project management, accurate documentation, troubleshooting, RCAs, CAPA, and

Qualifications

• Biotech manufacturing operations experience required.
• Experience coordinating cross-functional teams in GMP environments.
• Strong documentation and technical writing skills.
• Lean/OE experience and continuous improvement mindset.

Responsibilities

• Lead NPI coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality to introduce new Drug Substance products into the plant.
• Ensure production documents are accurate and up to date.
• Assist troubleshooting, problem-solving and RCAs; support CAPA development.
• Own NPI Change Controls and drive on-time completion; respond to regulatory questions.
• Champion Lean Transformation and OE initiatives to improve plant productivity and scheduling.

Skills

Cross-functional PM

Communications

Technical writing

Lean transformation

Education

High school diploma / GED

Associates degree

Bachelor's degree

Master's degree in chemistry/biology/engineering

Doctorate degree

Tools

Project management tools

Job description

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

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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.

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.