Remote Senior Associate Project Manager – Biosimilars Ops

Amgen Inc. (IR); Thousand Oaks (CA); Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Total Rewards Plan

Flexible work models (remote & hybrid)

Retirement and Savings Plan

Medical/dental/vision coverage

Stock-based long-term incentives

Job summary

Amgen Inc. (IR) is seeking a Sr Associate Project Manager in the Biosimilars PD/Operations group in the U.S. The role manages analytical similarity sample workflows, coordinating data and documentation through regulatory submission and cross-functional collaboration.

You will work with a diverse team to ensure accurate data verification and compliant ELN/LIMS processes. The position emphasizes strong organizational skills, experience in biotech/pharma settings, and the ability to manage multiple

Qualifications

• Master’s degree or Bachelor’s degree with 2 years of Project Management experience
• Associate’s degree with 6 years of Project Management experience
• High school diploma / GED with 8 years of Project Management experience
• Experience supporting pharmaceutical R&D or biotech industry
• Experience coordinating regulatory documents throughout the document lifecycle
• Strong organizational skills with the ability to manage multiple priorities in a dynamic environment

Responsibilities

• Provide project management to technical teams developing biosimilar candidates through to regulatory approval
• Provide project management of biosimilar business unit analytical similarity sample management
• Collaborate with cross-functional teams to plan and maintain inventory
• Manage logistics for distribution of samples for testing and communicate data
• Create electronic laboratory notebooks (ELN) for sample submission
• Generate lot numbers, sample IDs, and retrieve data in LIMS and ELN
• Assist staff with ELN software navigation and work orders
• Conduct data verification and organize data for regulatory filings
• Archive documents in controlled repositories and ensure compliance with guidelines

Skills

Project management

Biotech/pharma knowledge

Cross-functional collaboration

Regulatory documentation

Data management systems

MS Word

MS Excel

Education

Master’s degree

Bachelor’s degree in life sciences

Associate degree

Tools

ELN software

LIMS

Document management systems

Job description

Amgen Inc. (IR) is seeking a Sr Associate Project Manager in the Biosimilars PD/Operations group in the U.S. The role manages analytical similarity sample workflows, coordinating data and documentation through regulatory submission and cross-functional collaboration.

You will work with a diverse team to ensure accurate data verification and compliant ELN/LIMS processes. The position emphasizes strong organizational skills, experience in biotech/pharma settings, and the ability to manage multiple