Sr Engineer - Commercial Drug Product Technologies, Process Engineering - United States
The Senior Engineer will operate in product and process development and/or manufacturing environments and will be responsible for the design and execution of characterization studies, evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes, author high-quality process transfer and other technical documents, and participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities. The Senior Engineer must apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering (equipment, automation, chemical, mechanical) principles to support non-conformance investigations and development of corrective/preventive actions. As a key contributor to Amgen’s commercialization development and aseptic process introduction into clinical and commercial facilities, the Senior Engineer must integrate and successfully utilize knowledge and information generated by cross functional (engineering, analytical, quality, regulatory, clinical and commercial manufacturing) teams to utilize Amgen platforms and capabilities to ensure success through the commercialization lifecycle.
Work with a team of process scientists and/or engineers to design, execute, document, and generate primary data packages related to process development and technology transfer, while applying their experience in aseptic processing, equipment, automation and unit operation characterization
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Support technology transfers of pipeline and commercial products as well as lifecycle management of commercial products
Deliver progress reports and presentations and ensure that management is aware of the current status and progress
Participate in global cross-functional teams, working effectively in a highly matrixed team environment to advance programs
Master’s degree & 3 years of Operations or Process Development experience
Bachelor’s degree & 5 years of Operations or Process Development experience
Associate’s degree & 10 years of Operations or Process Development experience
High school diploma / GED & 12 years of Operations or Process Development experience
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
Familiarity with aseptic processing, manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools
The ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
Problem solving and communication skills
Experience in a matrix team environment and interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
Knowledge of bringing new biotech products to market, across various dosage forms and delivery systems
Knowledge of formulation, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Experience with conducting statistical evaluations of data to evaluate statistical significance, assess potential correlations, evaluate process capability and/or perform Monte Carlo simulations.
Ability to learn and act on dynamic information at a rapid pace
Ability to travel domestically and internationally up to 25% of the time
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.