Process Development Senior Associate - Pivotal Attribute Sciences

Process Development Senior Associate – Pivotal Attribute Sciences What you will do In this vital role you will participate in protein characterization studies to support regulatory filings using HPLC/UPLC and mass spectrometry (MS). The candidate will also develop, qualify, and transfer analytical methods to Quality Control, and optimize and troubleshoot existing methods. They will collaborate with other process development departments to support commercial process development and process characterization studies in support of marketing applications. Perform method development and qualification studies using HPLC, UPLC, and Capillary Electrophoresis platforms. Perform chromatographic fractionation, peptide mapping, intact mass, and other LC‑MS studies to support product characterization and comparability studies. Author results in laboratory notebooks and method development reports, interfacing closely with Attribute Sciences Team Leads and Quality Control to transfer and troubleshoot qualified methods. Participate in the maintenance of Attribute Sciences instruments and assist the department in maintaining a phase‑appropriate good manufacturing practices (GMP) environment. Coordinate and perform attribute identification and characterization studies, including isolation and analysis of chromatography fractions, with a focus on evaluating critical quality attributes. Conduct and coordinate accelerated stability studies to define therapeutic degradative pathways. Evaluate novel platform analytical technologies to drive innovation. Perform experiments to help answer questions from health authorities. Collaborate with partner organizations during commercial process development, process characterization, and process validation studies to support marketing applications. Basic Qualifications Master’s degree OR bachelor’s degree and 2 years of scientific experience OR associate’s degree and 4 years of scientific experience OR high school diploma/GED and 6 years of scientific experience. Preferred Qualifications Scientific background in method development and product characterization for therapeutic proteins. Degree in biochemistry, analytical chemistry, protein chemistry, or related subject area. Excellent written and verbal communication skills, ability to multitask, and efficiently plan and follow through on complex projects. Self‑starter who values working in teams. Benefits The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $80,044.50 – $108,295.50. Health and welfare plans for staff and eligible dependents. Financial plans with opportunities to save toward retirement or other goals. Work/life balance and career development opportunities. Discretionary annual bonus program. Stock‑based long‑term incentives. Time‑off plans and flexible work models. EEO Statement 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. #J-18808-Ljbffr Amgen Inc. (IR)