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Process Development Senior Scientist
3 months 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.
Process Development Senior Scientist - Attribute Sciences
Live
What you will do
Lets do this Lets change the world In this vital role you will be responsible for development and qualification of analytical methods, the characterization of protein-based biologic therapies, and supporting process development activities.
Testing and characterization of protein products to support Drug Substance and Drug Product process development: Design and execute studies, interpret results, author technical reports and analytical CMC sections in regulatory documents.Development, qualification, remediation, and transfer of analytical methods (HPLC/UPLC, CE and Mass Spec). Author technical protocols, reports, and SOPs for analytical methods.Serve as analytical subject matter expert to support investigations and studies carried out by other functional areas.Effectively interfacing and collaborating with other functional area colleagues including Process development to support and advise design of characterization studies, data analysis and communicating results.Providing expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development.Providing characterization results and/or authoring sections of Amgens clinical trial and marketing applications, helping to refine Amgens analytical regulatory strategies.Other duties include data analysis, preparation of electronic notebook records of experimental data, authorship of technical protocols and reports, presentation of results at team meeting, and support for regulatory filings as needed.Serves as role-model for junior staff in laboratory environment, troubleshoots and maintains laboratory equipment.Work in a cross-functional team environment to advance therapies in late-stage development.Lead troubleshooting of complex technical issues.WinWhat we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an effective problem solver with these qualifications. Basic Qualifications:Bachelors degree and 5 years of scientific experienceMasters degree and 3 years of relevant job experienceDoctorate degree or doctorate degree (completed by July 2024)Preferred Qualifications:Degree in analytical chemistry, physical chemistry, biochemistry, pharmaceutical sciences, or related subject area.Excellent laboratory skills with 4+ years of laboratory research or experience in industry laboratories supporting analysis and characterization of protein therapies.Direct experience within an industrial laboratory performing methods development to support biologics quality testing.Demonstrated expertise in mass spectrometry, liquid chromatography, and protein chemistry, including glycoproteins analysis, with a proven track record of successful LC and LC-MS method development.Expertise in capillary electrophoresis.Experience solving sophisticated problems, ability to work independently, proactively seek outside resources and collaborate, self-starter and team player with strong leadership and decision-making skills capable of providing mentorship to junior staff.Experience with data processing and statistical analysis software tools.Ability to lead small projects and / or work packages.Ability to work in a matrix team environment and collaborate effectively.Excellent written and verbal communication skills, ability to multitask, effectively plan and follow through on complex projects.Experience with use of electronic notebooks.Skilled in phase-appropriate GMP compliance and documentation.Experience supervising or guiding the work of others.ThriveWhat 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. #obesity