Specialist Stability

Career CategoryQualityJob DescriptionJoin Amgen's Mission of Serving PatientsAt Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we've helped pioneer the world of biotech in our fight against the world's 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, you'll 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, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.SPECIALIST STABILITYWhat you will doLet's do this. Let's change the world. In this vital role you will be an individual contributor providing critical support to a Product Quality Team (PQT) by managing the stability program for late stage clinical and commercial products and providing data management support for additional aspects of the PQT and regulatory reporting.The Specialist Stability builds and monitors product stability studies within compliant GMP quality systems (e.g., LIMS, Veeva), organizes and manages product quality and stability data, serves as a primary author on regulatory filing sections, and supports site-based GMP inspections. In addition, the Specialist Stability may provide business process improvements by authoring standard operating procedures (SOPs) or supporting the development of electronic data management tools (e.g., Spotfire applications). The role is based at the Amgen facility in Hyderabad, India.Roles & ResponsibilitiesBuild, monitor, and manage product stability studies in GMP quality systems (e.g., Veeva, LIMS, SampleManager)Author and maintain GMP technical documents and stability reports in compliant systemsProvide stability data reports using electronic reporting tools (e.g., Spotfire, SHINY)Collate, review, verify, and archive GMP stability and product quality dataCoordinate stability study starts and sample requests with global teamsParticipate in audits and inspections across multiple sites, ensuring readiness and complianceCollaborate with offshore teams to support Annual Product Reviews and Annual Reports of Minor ChangesMentor and train staff, sharing expertise to strengthen team capabilitiesWhat we expect of youBasic Qualifications:Doctorate Degree in a Life Sciences or Engineering field ORMaster's degree and 10 years of Quality, Operations, Scientific, or Manufacturing experience ORBachelor's degree and 12 years of Quality, Operations, Scientific, or Manufacturing experienceMust-Have Skills:Thorough understanding of GMP requirements, US FDA, and ICH regulationsStrong scientific data management and organizational skills with exceptional attention to detailProven experience in managing the product stability life cycleProven technical writing skills with ability to author regulatory-quality documentsAbility to deliver accurate results on time within GMP quality systems (Veeva, LIMS, Spotfire)Excellent written and verbal communication skills across all levels of the organization, with the ability to build cross-functional relationshipsProven ability to work independently and manage time-sensitive activities across teamsContinuous improvement mindset with experience applying lean practicesProficiency in MS Office (Word, Excel, PowerPoint, Teams)Good-to-Have Skills:Experience managing GMP stability programs for pharmaceutical products in compliance with FDA and ICH regulationsExperience with authoring, assembling, and reviewing annual product reviewsExpertise in GMP applications (Veeva, Spotfire, SHINY) and proficiency in MS Office (Word, Excel, PowerPoint, Teams)Experience collaborating across time zones in a global, matrixed team environmentSoft Skills:Strong analytical and problem-solving mindsetStrong initiative and self-motivation to drive results under pressureAbility to work independently and balance multiple priorities while meeting challenging deadlinesTeam-oriented approach with a focus on achieving shared goalsStrong presentation and public speaking skills for inspections and cross-team updatesWhat Success Looks LikeTimely and accurate execution of stability studies and reportsReadiness for audits and inspections with robust, compliant documentationEffective cross-functional collaboration to meet global PQT objectivesPositive impact on team development through mentoring and trainingWhat you can expect of usAs 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, we'll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.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..