Remote Senior Project Manager – Biosimilars Operations

Socket.dev; United States; Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Remote/hybrid work options

Total rewards plan

Job summary

Amgen is seeking a Sr Associate Project Manager to join the Biosimilars Business Unit PD/Operations. You will manage analytical similarity sample management from development through regulatory submission and support cross-functional teams to keep biosimilar programs on track.

The role requires strong organizational and communication skills, experience in project management, and familiarity with ELN/LIMS systems; remote and hybrid work options are available, and the company offers a comprehensive

Qualifications

• Master’s degree ORBachelor’s degree with 2 years of Project Management experience ORAssociate’s degree with 6 years of Project Management experience ORHigh school diploma/GED with 8 years of Project Management experience
• Experience coordinating scientific or regulatory documents throughout the document lifecycle
• Strong organizational and multitasking abilities in a fast paced environment

Responsibilities

• Provide project management to technical teams developing biosimilar candidates through to regulatory approval
• Manage biosimilar business unit analytical similarity sample management
• Collaborate with cross functional teams including Similarity Team, CRG, Data Management and scientific staff to plan and maintain inventory
• Coordinate logistics for distribution of samples for testing and communicate incoming data
• Create ELN entries for sample submission and generate lot numbers and data retrievals in LIMS
• Assist staff with ELN updates, database queries, data review and verification with Data Management
• Assist in data verification for internal documents and regulatory filings
• Format documents to Amgen style guidelines and standards

Job description

Amgen is seeking a Sr Associate Project Manager to join the Biosimilars Business Unit PD/Operations. You will manage analytical similarity sample management from development through regulatory submission and support cross-functional teams to keep biosimilar programs on track.

The role requires strong organizational and communication skills, experience in project management, and familiarity with ELN/LIMS systems; remote and hybrid work options are available, and the company offers a comprehensive