The Engineer will join Drug Product Process Engineering team that is part of Commercial Drug Product Technologies at Amgen and will be a key contributor to drug product process development, commercialization, and life cycle management of Amgens parenteral product portfolio. The Engineer will be responsible for integrating the knowledge and information generated by cross functional teams with Amgens platforms and clinical and/or commercial manufacturing capabilities to ensure success through the commercialization lifecycle. The Engineer will operate in product/process development and aseptic manufacturing environments in a highly matrixed cross functional manner. This position is based in Thousand Oaks, CA at the Amgen headquarters.
Support technologytransfers ofearly pipeline (FIH) to commercial products, including lifecycle management, for a variety of parenteral modalities
Conduct make-a-batch exercises to resolve facility fit and identify gaps
Evaluation of product impact from manufacturing process, production scale, equipment, and raw material changes
Author and/or own high-quality process technology transfer and other technical documents
Participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio
Work directly with clinical and commercial manufacturing in support of ongoing production, new product introductions, new technology introduction, and process optimization
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
Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineering
Participate in global multi-functional teams, working effectively in a highly matrixed team environment to advance technology transfer projects as well as improvement initiatives
Deliver progress reports and presentations (including generation and upkeep of dashboard) to engage with and ensure that management is aware of the current status and progress
Bachelors degree & 3 years of Operations or Process Development experience
M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, vials, syringes, cartridges, devices, disposables, modeling and the associated GMP/Device documentation and regulatory filings
Technology transfer experience across different development phases, fill-finish process scale-up, and the use of gap analysis, root cause analysis, and risk assessment tools
Strong experience in a matrix team environment, interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and Quality
Familiarity with aseptic processing, drug product 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
Highly proficient in presentation skills and the ability to draft technical documents.
Ability to learn and act on dynamic information at a rapid pace
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.