Sr Associate Project Manager - Remote

Career Category Project Management Job Description Join Amgen’s Mission of Serving Patients At 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Sr Associate Project Manager  Live What you will do Let’s do this. Let’s change the world. The Project Manager will work in the Biosimilars Business Unit PD/Operation group, responsible for analytical similarity sample management of biosimilar programs to commercialization.   Manages/optimizes routine workflows to support technical teams responsible for developing biosimilar candidates through to regulatory approval. Regularly interacts with management and cross-functional contacts. Skills: strong analytical skills; strong MS Word and MS Excel skills; knowledge of good data practices/data verification, understanding of systems for sharing and collaboration; excellent communication skills. Responsibilities • Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval • Provide project management of biosimilar business unit (BBU) analytical similarity sample management. • Collaborate closely with cross-functional team including Similarity Team, Critical Regents Group (CRG), Data Management, and scientific staff to plan and maintain inventory. • Manage logistics for distribution of samples for testing and communicate incoming data for biosimilar projects. • Create electronic laboratory notebooks (ELN) for sample submission. • Generate lot number, sample ID, and retrieving data in QC LIMS. • Assist BBU staff with navigating ELN software and placing work orders for ELN updates. Database queries of LIMS, ELN and other databases including the compiling and organizing data to review, verify independently or in coordination with Data Management. • Retrieve and organize data for review with Data Management • Document archival in controlled document repository • Provide data verification as needed for internal documents and regulatory filings in controlled document system. • Utilize a strong foundation in scientific principles to thoroughly review regulatory documents and accurately determine the data elements that require verification in accordance with established protocols. • Collaborate with cross-functional teams to ensure the completion and accuracy of the data verification processes. • Assist in formatting documents in compliance with Amgen's internal style guidelines and standards. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Sr Associate Project Manager ​we seek is a motivated professional with these qualifications.

Master’s degree OR Bachelor’s degree and 2 years of Project Management experience OR Associate’s degree and 6 years of Project Management experience OR  High school diploma / GED and 8 years of Project Management experience Preferred Qualifications: Experience