About the position
Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Responsibilities
- 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.
- 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 products for a variety of parenteral modalities.
- Conduct make-a-batch exercises to determine facility fit and identify gaps.
- Design and execution of offline and on-site drug product characterization studies.
- 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.
Requirements
- High school diploma / GED and 8 years of Operations or Process Development experience OR
- Associate's degree and 6 years of Operations or Process Development experience OR
- Bachelor's degree and 2 years of Operations or Process Development experience OR
- Master's degree
Nice-to-haves
- M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline.
- Experience in a role that working with cross functional groups to achieve results.
- Highly proficient in presentation skills and the ability to draft technical documents.
- 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.
- 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.
- Ability to learn and act on dynamic information at a rapid pace.
- 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.
Benefits
- A 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.
- Flexible work models, including remote and hybrid work arrangements, where possible.
