Manufacturing NPI Specialist - Downstream Readiness

About the role

Amgen is hiring a Specialist Manufacturing New Product Introduction (NPI) for downstream readiness at its Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. As part of the Manufacturing Support team, the role bridges GMP manufacturing teams and Process Development scientific groups to ensure new products are successfully introduced into the facility. It is a highly visible role focused on hosting cross-functional meetings to drive timelines for tech transfer, and it offers the chance to propose, participate in and lead team improvement initiatives.

Key responsibilities

• Lead coordination with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, Quality and other teams to introduce new Drug Substance products and advanced technologies using project management tools.
• Ensure production documents are accurate and up to date, and support troubleshooting, problem solving and root cause analyses (RCAs).
• Support CAPA development to prevent errors from recurring.
• Own NPI change controls and collaborate with stakeholders to meet deadlines.
• Respond to regulatory questions and audit findings.
• Champion Lean Transformation and Operational Excellence initiatives, track progress at plant level and promote continuous improvement.

Required profile

• Biologics drug substance manufacturing background with strong cross-functional project management and communication skills.
• Basic qualification: high school diploma / GED and 10 years of biotechnology operations experience, or associate's degree and 8 years, or bachelor's degree and 4 years, or master's degree in chemistry, biology or engineering and 2 years, or doctorate.
• Preferred: degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry; GMP manufacturing experience; lean manufacturing and operational excellence background.

Required skills

• Strong technical knowledge of drug substance processing in cell culture or purification (chromatography, filtration, buffer compounding).
• Ability to analyze technical data through trend analysis, forecasting and modeling.
• Excellent technical writing and presentation skills, and ability to coach, mentor or cross-train colleagues.

What we offer

• Annual base salary range of $107,545 to $145,502 in the U.S.
• Health, dental and vision coverage, life and disability insurance, and a retirement savings plan with company contributions.
• Discretionary annual bonus or sales-based incentive plan, stock-based long-term incentives, and time-off plans.
• Flexible work models, including remote work where possible.