Sr Engineer
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. Sr Engineer What you will do and what we expect of you Let’s do this. Let’s change the world. In this vital role you will: Duties: Act as a drug product technical authority, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to compression, blending, milling, granulation, drying, compaction and coating; Lead via cross-site teams, and in general by setting the agenda and identifying potential issues; Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production; Tackle issues with drug product processing technologies and equipment; Identify and manage implementation of operational improvement opportunities for current and new processes; Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA; and Visit contract manufacturing sites to support key production breakthroughs and establish relationships. Position requires up to 25% of travel to various unanticipated worksites nationally and internationally. May telecommute.
Requirements
- Apply engineering and scientific principles to design and implement wet granulation, roller compaction, blending, milling, drying, compression, encapsulation and coating processes.
- Process Characterization, Technical Transfer to commercial drug product sites, and Process Validation of oral solid drug products.
- Project management skills utilizing tools including Microsoft Project
- Quality and regulatory systems including TrackWise, drug product manufacturing, and process validation
- Apply problem solving methodologies including fishbone diagrams and 5 whys to RCA investigations.
- Identify and evaluate critical process parameters including statistical analysis.
Responsibilities
- Act as a drug product technical authority, to provide leadership and solutions when troubleshooting oral solid drug product manufacturing, for all unit operations including but not limited to compression, blending, milling, granulation, drying, compaction and coating
- Lead via cross-site teams, and in general by setting the agenda and identifying potential issues
- Provide process development expertise for commercial drug product processing in specific areas such process characterization, technology transfer, process validation and routine commercial production
- Tackle issues with drug product processing technologies and equipment
- Identify and manage implementation of operational improvement opportunities for current and new processes
- Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA
- Visit contract manufacturing sites to support key production breakthroughs and establish relationships
Benefits
- stock
- retirement
- medical
- life and disability insurance
- eligibility for an annual bonus
- health and welfare plans for staff and eligible dependents
- financial plans with opportunities to save towards retirement or other goals
- work/life balance
- career development opportunities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
