Sr Associate Project Manager - Remote

Amgen is a biotechnology company focused on developing and delivering innovative medicines for serious illnesses. The Sr Associate Project Manager will support the Biosimilars Business Unit by managing analytical similarity sample workflows, coordinating cross-functional teams, organizing scientific and regulatory data, and ensuring data verification and document compliance through commercialization.

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

Requirements:

• Master's degree
• Bachelor's degree and 2 years of Project Management experience
• Associate's degree and 6 years of Project Management experience
• High school diploma / GED and 8 years of Project Management experience
• Experience supporting pharmaceutical research and development or nonclinical drug development programs within the biotechnology, pharmaceutical, or life sciences industry
• Experience working with document management systems, collaboration platforms, and project management tools
• Experience coordinating scientific or regulatory documents throughout the document lifecycle
• Strong organizational skills with the ability to manage multiple priorities in a dynamic, fast-paced environment
• Bachelor's or advanced degree in a life science discipline, regulatory affairs, business, or a related field