Specialist Manufacturing:New Product Introduction (NPI): CCMS/BOM

New Product Introduction (NPI)

Communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. Responsible for ensuring new products are successfully introduced into ANC’s biologics manufacturing facility. Host cross-functional meetings to drive timelines to support the tech transfer of the program into the facility.

• Coordinate 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.
• Lead or participate in projects to ensure production documents are accurate and up-to-date.
• Support Manufacturing in troubleshooting, problem-solving, and RCA (Root Cause Analysis).
• Develop CAPA (Corrective and Preventative Actions) to prevent error recurrence.
• Own New Product Introduction (NPI) Change Controls and collaborate with stakeholders to drive on-time completion.
• Respond to regulatory questions and/or audit findings.
• Champion Lean Transformation and OE (Operational Excellence) initiatives, facilitate continuous improvement in the plant, and track progress on a plant level.

Basic Qualifications

• High school diploma/GED and 10 years of biotechnology operations experience
• Associates degree and 8 years of biotechnology operations experience
• Bachelor’s degree and 4 years of biotechnology operations experience
• Masters degree in chemistry, biology, or engineering and 2 years of biotechnology operations experience
• Doctorate degree

Preferred Qualifications

• Chemical Engineering, Industrial Engineering, Biology, or Biochemistry degree
• Strong cross-functional project management, meeting facilitation, and technical writing skills
• Experience in GMP manufacturing operations
• Technical knowledge of drug substance processing in Cell Culture or Purification (chromatography, filtration, buffer compounding)
• Ability to organize, analyze, and interpret technical data through trend analysis, forecasting, modeling, etc.
• Effective communication of complex technical information with internal and external colleagues
• Ability to coach, mentor, or cross-train colleagues within core technical areas
• Background in lean manufacturing methodologies and operational excellence

Win What We Expect of You

• Unique contributions to serve patients
• Biologics DS manufacturing background with strong cross-functional project management and communications skills

Thrive What You Can Expect of Us

• Annual base salary range in the U.S. provided
• Total rewards plan comprising health and welfare plans, financial plans, work/life balance, and career development opportunities
• Comprehensive employee benefits package including retirement and savings plans, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• Discretionary annual bonus program or sales-based incentive plan for field sales representatives
• 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