Sr Associate Project Manager - Remote

About the Role

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.

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

Basic 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 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

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

Benefits

• Retirement and Savings Plan with generous company contributions
• Group medical, dental and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives)
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote and hybrid work arrangements, where possible