Manufacturing Programs Senior Manager: New Product Introduction (NPI)

BioSpace; Holly Springs (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

Amgen in North Carolina seeks a Manufacturing Programs Senior Manager to lead New Product Introduction (NPI) at the biologics Drug Substance site. You will coordinate with Manufacturing, Process Development, Supply Chain, Planning, Facilities and QA to ensure smooth tech transfers and robust documentation.

This role drives cross-functional delivery, leads a team of NPI manufacturing specialists, champions Lean and Operational Excellence, and interfaces with Process Development and Manufacturing

Qualifications

• Doctorate/masters/bachelors/associates/high school with biotechnology operations experience.
• Minimum 2 years of people leadership or project leadership experience.

Responsibilities

• Coordinate NPI with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, QA.
• Rapid problem-solving to resolve technical challenges.
• Lead a team of NPI manufacturing specialists and foster staff growth.
• Ensure production documents are accurate and up to date.
• Support Manufacturing in troubleshooting, RCAs, and CAPA development.
• Champion Lean Transformation and OE initiatives; track plant-level progress.

Skills

Cross-functional project management

Communication skills

Lean manufacturing

Operational excellence

Problem solving

Education

Doctorate + biotech ops

Masters + biotech ops

Bachelors + biotech ops

Associates + biotech ops

High school + biotech ops

Tools

GMP manufacturing operations

Job description

Manufacturing Programs Senior Manager: New Product Introduction (NPI)

What You Will Do

Lets do this. Lets 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 ANCs Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANCs biologics manufacturing facility. It is a highly visible role across the site with the core responsibility of driving cross‑functional deliverables supporting the tech transfers 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) subject matter expert 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.
• Rapid problem‑solving capabilities to help the team resolve technical challenges.
• Leading a team of NPI manufacturing specialists while building a culture that helps staff thrive.
• 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.
• Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant, and tracks progress on a plant level.

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

• Doctorate degree and 2 years of biotechnology operations experience
• Masters degree in chemistry, biology or engineering & 6 years of biotechnology operations experience or
• Bachelors degree and 8 years of biotechnology operations experience or
• Associates degree & 10 years of biotechnology operations experience or
• High school diploma / GED & 12 years of biotechnology operations experience
• AND In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

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

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.

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.