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Process Development Senior Associate

Company: Amgen SA
Location: Cambridge
Posted on: November 25, 2022

Job Description:

HOW MIGHT YOU DEFY IMAGINATION?You've 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 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.Process Development Senior AssociateLiveWhat you will doLet's do this! Let's change the world! Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes state-of-the-art analytical tools to guide that development. The Pivotal PD organizations focus is developing and commercializing robust manufacturing processes across a wide range of therapeutic modalities, including (but not limited to) monoclonal and bispecific antibodies, bispecific T-cell engagers, live oncolytic viruses, and synthetic medicines.Located in our Cambridge, MA office, the PD Sr. Associate will work within the Rapid Analytics team of Pivotal Attribute Sciences to provide testing support for commercial process development and process characterization studies for clinical candidate molecules in the pivotal stage of development.Responsibilities:

  • Obtain assignment and follow scientific direction of Rapid Analytics managers, flag issues and seek guidance appropriately.
  • Perform testing and data review for the analysis of proteins and peptides using HPLC/UPLC (high and ultra-high liquid chromatography), titer, small scale protein purification using TECAN and plate reader, CE (capillary electrophoresis), CEX (cation exchange), HILIC (hydrophilic interaction).
  • Utilize high-throughput, robotics sample handling and/or auto-sampler systems to manage samples, purify, and test
  • Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
  • Operate specialized laboratory equipment and instrumentation.
  • Perform general laboratory housekeeping activities.
  • Complete training on assigned tasks.
  • Participate in quality improvement efforts.
  • Comply with safety guidelines and site-specific procedures which include but is not limited to, the maintenance of training records, laboratory documentation, written procedures, building monitoring systems and laboratory log books.
  • Interact with multiple functional areas in a highly matrixed-team environment, which may include Manufacturing, Process Development, IS, Facilities, Engineering, and Quality Control.WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The highly organized professional we seek is a continuous learner with these qualifications.Basic Qualifications:
    • Master's degreeOR
      • Bachelor's degree with 2 years of Scientific experiencePreferred Qualifications:
        • B.S. in Biochemistry
        • Excellent general biochemistry laboratory skills
        • Experience executing analytical test methods in chromatography including HPLC, UPLC, and CE
        • Background with compendial methods testing, such as Karl Fischer, Color/Clarity, and UV/VIS spectroscopy
        • Strong desire to learn and interest in science
        • Demonstrated proficiency in method development and experience with method technology transfer. Background in chromatography data software (Waters Empower -, Thermo Chromeleon -) and/or automation software (Tecan -)
        • Understanding of phase-appropriate GMP compliance and documentation
        • Well-organized; ability to multitask, effectively plan and follow through on complex projects, and to work both independently and in teamsThriveSome of the vast rewards of working hereAs 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.
          • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
          • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
          • Generous 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 Us If 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. 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. Amgen requires all staff in the United States, Puerto Rico and Canada 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.

Keywords: Amgen SA, Cambridge , Process Development Senior Associate, Accounting, Auditing , Cambridge, Massachusetts

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