Specialist Manufacturing: Process Owner, Manufacturing Services

Amgen•Holly Springs, NC

13d

About The Position

Amgen is seeking a Specialist Manufacturing: Process Owner, Manufacturing Services to join their team at the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant. This role serves as a key interface between GMP manufacturing teams and Process Development scientific groups. The position is responsible for the ownership of manufacturing services operations, specifically focusing on process ownership for unit operations including media preparation, buffer preparation, and manufacturing material kitting and transportation. This is a highly visible role within the site, contributing to Amgen's newest and most advanced drug substance manufacturing facility, the FleX Batch facility, which combines disposable technologies with traditional stainless-steel equipment and integrates industry 4.0 capabilities and sustainability innovations.

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

Serve as the manufacturing services technical expert, leading weigh and dispensing operations, media and buffer solution preparations.
Participate in projects, including aiding in commissioning and qualification, and training staff on single-use technology, analytical equipment, and processes.
Coordinate with New Product Introduction (NPI) team, Manufacturing, Process Development, Supply Chain, Facilities and Engineering, and Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (e.g., Smartsheet).
Support Manufacturing in troubleshooting, problem-solving, and participating in deviation Root Cause Analyses (RCAs).
Own CAPA (Corrective and Preventive Actions) and Change Controls to prevent error recurrence and drive continuous improvement.
Ensure 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, Process Performance Qualifications (PPQs), and/or during the implementation of new technologies.