Sr Associate Project Manager - Remote
About The Position
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.
Requirements
- 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
Nice To Haves
- 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.
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.
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
