Amgen

Amgen

Manufacturing Programs Senior Manager: New Product Introduction (NPI)

US - North Carolina - Holly Springs · Senior

Sponsorship not specifiedDetected 70 days ago
Project ManagementForecastingSupply ChainGMPCell CultureLeadershipCommunicationProblem SolvingWritingLean Manufacturing

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odds of building a lasting career here

38Risky
Cap-exempt (no lottery)0
Sponsors this role85
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Green-card follow-through: 92%

Of 75 labor certifications old enough to have been used, 6 expired without the employer filing the next step. Median time from filing to decision: 486 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.

Files H-1B transfers

17 transfer filings in the last year, covering 17 workers. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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About the role

  • 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?
  • It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide.

Responsibilities

  • 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.
  • This role will also offer the opportunity to propose, participate, and lead team improvement initiatives to drive improved productivity and scheduling accuracy.

Requirements

  • Doctorate degree and 2 years of biotechnology operations experience
  • Master's degree in chemistry, biology or engineering & 6 years of biotechnology operations experience or
  • Bachelor's degree and 8 years of biotechnology operations experience or
  • Associate's degree & 10 years of biotechnology operations experience or
  • High school diploma / GED & 12 years of biotechnology operations experience
  • Your managerial experience may run concurrently with the required technical experience referenced above

Nice to have

  • 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.

Compensation

  • 154,173.00USD -208,587.00 USD

Company info

  • Be part of Amgen's newest and most advanced drug substance manufacturing plant.
  • Win What we expect of you We are all different, yet we all use our unique contributions to serve patients.
  • We are all different, yet we all use our unique contributions to serve patients.
  • 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.

This listing is sourced directly from Amgen's careers page and normalized into a canonical job model.