Process Development Product Engineer

Company: Amgen
Location: Somerville
Posted on: May 3, 2021

Job Description:

Career CategoryProcess DevelopmentJob DescriptionHOW MIGHT YOU DEFY IMAGINATION?You've earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you've worked hard to acquire and the passion you already have. At Amgen, our shared mission"to serve patients"drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.PROCESS DEVELOPMENT PRODUCT ENGINEERLiveWhat you will doLet's do this. Let's change the world. In this vital role you will join our contract manufacturing organizations across the world and resolve challenges encountered in commercial production of oral solid drug products.This role will be based out of Amgen Massachusetts, as part of the global Process Development organization and will support new product introductions, lifecycle changes and ongoing commercial ternational travel to visit contract manufacturing partner sites.Responsibilities:Develop as a drug product technical professional, to provide leadership and solutions solving problems oral solid drug product manufacturing, for unit operations including but not limited to encapsulation, blending, milling, granulation, drying, compression and coating.Work with Contract Manufacturing partners, Global Operations, Contract Manufacturing Quality, and Drug Product process teams.Participate in cross site team meetings to support contract manufacturers and to identify and resolve potential issues.Provide process development expertise for commercial drug product processing in specific areas such as process characterization, technology transfer, process validation and routine commercial production.Solve issues with drug product processing technologies and equipment.Identify and implement operational improvements for drug product commercial processes.Support commercial drug product manufacturing operations and contract manufacturing quality with technical evaluation of NC/CAPA.Visit contract manufacturing sites to observe production operations and build relationships.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a collaborative team-player with these qualifications.Basic Qualifications:Master's degreeORBachelor's degree and 2 years of pharmaceutical manufacturing experienceORAssociate's degree and 6 years of pharmaceutical manufacturing experienceOrHigh school diploma / GED and 8 years of pharmaceutical manufacturing experiencePreferred Qualifications:Masters in a Science or Engineering or a related discipline.3+ years of experience in applying fundamental engineering and scientific principles to the design and implementation of wet granulation, roller compaction, blending, milling, drying, compression, coating and encapsulation processes.Experience managing contract manufacturing organizations (CMOs).Project management experience.Experience leading multiple projects and get results.Knowledge of pharmaceutical manufacturing processing in a GMP environment.Problem-solving ability and collaboration.Excellent oral and written communications skills.Strong academic results in a bachelor's degree in Science, Engineering or a related subject area.ThriveSome of the vast rewards of working hereAs we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journeyA diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan"comprising health, finance and wealth, work/life balance, and career benefits"with compensation and benefits rated above 4 stars (out of 5) on GlassdoorApply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join Equal Opportunity StatementAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation. .Full timeSDL2017

Keywords: Amgen, Somerville , Process Development Product Engineer, Other , Somerville, Massachusetts