Principal Scientist

Company: Amgen
Location: Cambridge
Posted on: July 12, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Principal Scientist What you will do Lets do this. Lets change the world. In this vital role you will apply your knowledge and skills to perform analytical development of late-stage biological therapeutics. In your daily work you will: Interface and collaborate with other functional areas in matrix environment, serving as analytical subject matter expert to support and advise design of characterization studies, data analysis and investigations. Provide analytical testing support to functions including but not limited to Drug Substance Technologies, Quality, and Manufacturing Leverage latest advances in protein analytics to develop, optimize, troubleshoot, remediate, qualify, validate and transfer analytical methods Design and execute analytical studies to support process and product characterization for late stage development products utilizing protein chemistry, separation sciences and mass spectrometry Interpret results, author technical protocols, reports, analytical method descriptions and analytical CMC sections in regulatory documents Lead project teams and/or project sub-teams to meet program goals Provide expertise and evaluation of Amgens platform and analytical technologies, helping to drive innovation and efficiency within Process Development. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Scientific professional we seek is a leader with these qualifications. Basic Qualifications: Bachelors degree and 7 years of Scientific experience; Or Masters degree and 5 years of Scientific experience; Or Doctorate degree PhD OR PharmD OR MD and 2 years of Scientific experience Preferred Qualifications: Advanced degree in Analytical Chemistry or related area with extensive experience performing independent scientific research Four or more years of experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing. Strong and in-depth expertise in multiple analytical techniques (i.e., SE-HPLC, RP-HPLC, CE, LC-MS); characterization of protein modifications with glycan mapping and peptide mapping. Experience in method transfers, method validation, method troubleshooting, and complex investigations. Familiarity with and understanding of United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation. Experience in authoring and review of regulatory submission product quality sections and supporting documentation. Experience preparing for and responding to RTQ, including assessment of CQAs, product quality targets and attribute risk assessment. Strong oral and verbal communication skills, ability to interact effectively with diverse internal and external stakeholders. Proficiency in solving complex problems, ability to work independently, proactively seek outside resources and collaborate, ability to multitask, effectively plan and follow through on complex projects. A self-starter with strong decision-making skills, who thrives in collaborative matrix environment and can provide cross-functional leadership and mentorship to junior staff. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way. 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. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: 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 Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. 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.

Keywords: Amgen, Plymouth , Principal Scientist, Science, Research & Development , Cambridge, Massachusetts