Specialist Manufacturing New Product Introduction (NPI):Downstream Readiness

Amgen; Holly Springs (NC); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement savings plan

Stock-based incentives

Annual bonuses

Flexible work arrangements

Job summary

Amgen in North Carolina seeks a Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness to coordinate NPI activities for Drug Substance products and advanced tech introductions. You will drive cross‑functional meetings, ensure documentation accuracy, and lead improvement initiatives to enhance productivity and scheduling accuracy.

The role requires strong project management, GMP experience, and the ability to communicate complex technical information with diverse teams.

Qualifications

• Bachelor’s or higher degree with relevant biotech operations experience.
• Experience in GMP manufacturing operations is preferred.
• Ability to communicate complex technical information effectively.

Responsibilities

• New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities, 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 continuous improvement in the plant, and tracks progress at a plant level.

Education

High school diploma / GED & 10 years biotech ops experience

Associate’s degree & 8 years biotech ops experience

Bachelor’s degree & 4 years biotech ops experience

Master’s degree in chemistry, biology, or engineering & 2 years biotech ops experience

Doctorate degree

Job description

Specialist Manufacturing New Product Introduction (NPI): Downstream Readiness

In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina 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, hosting cross‑functional meetings to drive timelines, and leading improvement initiatives to enhance productivity and scheduling accuracy.

Responsibilities

• New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities, 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 continuous improvement in the plant, and tracks progress at a plant level.

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.

What You Can Expect Of Us

• 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.

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.