Manager - Stability

Career CategoryQualityJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.ABOUT THE ROLERole Description:The Stability function is part of the Amgen Product Quality organization, providing governance and management of lean, harmonized, and compliant Stability data packages for all of Amgen’s products.  In this team-based role, Manager Stability will collaborate with Product Quality Teams (PQTs), supporting specialist teams, and Global stability teams to ensure the design, management, maintenance, and data analysis of a product’s stability program support GMP compliance and meet the Market Authorization commitments. In this management role you will provide critical support to PQTs through management of activities and staff supporting different programs for late-stage clinical and commercial products.In this team-oriented manager role, you will serve as a subject matter expert of GMP data management strategy, directly adding to the success of PQTs by ensuring support for the product Quality strategies. In this role, you will be working closely with diverse functional groups including Supply Chain, Manufacturing, Global CMC Statistics, External Supplier Quality, Quality Control, Regulatory, Quality Assurance, external providers, and other departments on a variety of activities. Such activities include managing data standardization activities, Chromatographic overlays, data verification and, where warranted, investigations, regulatory submissions and support for inspections across the Amgen manufacturing and testing network.   Roles & Responsibilities:Directly supervise Quality staff supporting Product Quality Teams and activities enabling regulatory submissionsAdeptly manage staff training and independently coordinate staff assignments supporting time-sensitive activities across multiple teamsAuthor, revise, review, and approve technical documents in GMP Quality systems, including but not limited to data reports, Standard Operating Procedures, and Work InstructionsWork closely with the global Product Quality organization to drive standardization of data, Chromatographic overlays and data verification activitiesLead continuous improvement projects that may be global or local in scopeOwn, manage, and participate in deviations, CAPAs, and cross functional investigationsCommunicate and collaborate with cross-functional teams across multiple sites and time zones to coordinate stability study starts and sample requestsParticipate in audits and inspections across multiple sitesMentor and train staff, as requiredBasic Qualifications and Experience:Master's degree in chemistry, biochemistry, biology, or a related pharmaceutical sciences field and above 10 years of Quality, Operations, Scientific experience.Functional Skills:Must-Have Skills:Experience and expertise in managing teams and motivating staff to deliver high quality results and adhere to project timelines using digital GMP Quality systemsDemonstrated proficiency and knowledge in biologics manufacturing processes including analytical methods, cGMP, and international regulatory expectationsDemonstrated proficiency is oral and written communication of complex informationAbility to build and maintain cross-functional relationships and strong partnerships through written and verbal communication skillsExceptional attention to detail and accuracy in all deliverablesStrong scientific data management and organization skillsExpertise with chromatography systems, Laboratory Information Management SystemsExpertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., MS Teams)Effective communication, critical thinking and problem solvingGood-to-Have Skills:Experience working virtually on a cross-functional team in a matrix environment across multiple time zonesExpertise in computer applications such as Veeva, Spotfire, SHINYExpertise in MS Office (Word, Excel, PowerPoint, MS Teams)Soft Skills:Analytical and problem-solving skillsAbility to work effectively with global, virtual teamsHigh degree of initiative and self-motivationAbility to manage multiple priorities successfully, react quickly to address urgent requests and meet challenging timelinesTeam-oriented, with a focus on achieving team goalsStrong presentation and public speaking skillsEQUAL OPPORTUNITY STATEMENTAmgen 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 with 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 an accommodation..