Specialist Manufacturing: Process Owner, Manufacturing Services

Amgen • Holly Springs, NC

1d • Onsite

About The Position

Amgen is seeking a Specialist Manufacturing: Process Owner, Manufacturing Services for its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for flexible operations and integrates industry 4.0 capabilities and sustainability innovations. The role involves communicating and interfacing between GMP manufacturing teams and Process Development scientific groups, with a core responsibility for process ownership of manufacturing services unit operations, including media preparation, buffer preparation, and manufacturing material kitting and transportation.

Requirements

• Doctorate degree OR Master’s degree in chemistry, biology, or engineering & 3 years of biotechnology operations experience or Bachelor’s degree and 5 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

Nice To Haves

• Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
• Excellent cross-functional project management, meeting facilitation, and technical writing skills
• Experience in Downstream GMP manufacturing operations
• Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) 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

Responsibilities

• Manufacturing services technical expert who leads weigh and dispensing operations, media and buffer solution preps.
• Participates in projects, including aiding in commissioning and qualification and training staff on single-use technology, analytical equipment and processes.
• Coordinating with New Product Introduction (NPI) team, Manufacturing, Process Development, Supply Chain, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).
• Support Manufacturing in troubleshooting, problem solving and participating in deviation RCAs.
• Own and CAPA and Change Controls to prevent error recurrence and continuous improvement.
• Ensure that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and align with electronic batch records.
• Lead tabletop and water runs to test records and SOP updates prior to use before major changes.
• Provide hypercare support during first batch runs, PPQs, and/or during implementation of new technologies.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees