Senior Engineer
2 weeks ago
HOW MIGHT YOU DEFY IMAGINATION?
Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Engineer - Drug Product Process EngineeringLive
What you will do
Lets do this. Lets change the world. In this vital role you will provide technical feedback and support to Amgens drug product commercialization process for multiple product modalities, by supporting technology transfer of products from development to clinical/commercial production. This role is critical for Amgens success and will be a key contributor to drug product and process development, commercialization, and life cycle management of Amgens parenteral and oral solid dosage form product portfolio.Responsibilities:
Work with a team of process scientists and/or engineers to design, implement, 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 characterizationAct as a drug product technical specialist, to provide leadership and solutions for parenteral product manufacturing, for all unit operations including but not limited to formulation, filtration, filling, capping, lyophilization and visual inspection.Support continuous improvements in the drug product development process through technological innovation and application of first principles in process engineeringSupport technology transfers of pipeline and commercial products as well as lifecycle management of products for a variety of parenteral modalitiesDeliver progress reports and presentations to engage with and ensure that management is aware of the current status and progressParticipate in global multi-functional teams, working effectively in a highly matrixed team environment to advance programs through clinical manufacturing and the commercialization processWinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The senior engineer professional we seek is a self-starter with these qualifications: Basic Qualifications: Doctorate degreeOr Masters degree and 2 years of Operations or Process Development experienceOr Bachelors degree and 4 years of Operations or Process Development experienceOr Associates degree and 8 years of Operations or Process Development experienceOr High school diploma / GED and 10 years of Operations or Process Development experience Preferred Qualifications:M.S. or PhD in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field5+ years of drug product process development experience in the pharmaceuticals/biotechnology industryFamiliarity with aseptic processing, drug product manufacturing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterizationProcess scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment toolsThe ability to use engineering principles to demonstrate bench and pilot scale models for process performance characterizationExperience in a matrix team environment, in particular interacting with Attribute Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or QualityKnowledge of bringing new products to market, across various dosage forms and delivery systemsKnowledge of associated GMP/Device documentation and regulatory filingsExperience 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 paceAbility to travel domestically and internationally up to 25% of the timeThriveWhat you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: 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 planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply nowfor a career that defies imagination Objects in your future are closer than they appear. Join us. Amgen 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 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 accommodation.-
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