Remote Senior Project Manager – Biosimilars Ops

Amgen; Washington (District of Columbia); Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Health, dental and vision coverage

Stock-based long-term incentives

Flexible work arrangements

Job summary

Amgen is seeking a Sr Associate Project Manager to lead biosimilar program management within the Biosimilars PD/Operation group. You will coordinate technical teams through to regulatory approval, manage ELN/data workflows, and ensure data integrity across LIMS, ELN, and related systems.

The role emphasizes strong organizational and communication skills, collaboration with diverse teams, and adherence to strict data management standards in a fast-paced environment.

Qualifications

• Master’s degree OR equivalent combination of education and PM experience.
• Bachelor’s degree with 2+ years of Project Management experience OR equivalent qualifications.
• Associate’s degree with 6+ years PM experience OR High school with 8 years PM experience.
• Experience supporting pharmaceutical R&D or biotech is preferred.

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, 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 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 determine data elements that require verification per protocols.
• Collaborate with cross-functional teams to ensure completion and accuracy of data verification processes.
• Assist in formatting documents in compliance with Amgen’s internal style guidelines and standards.

Skills

Analytical skills

Communication skills

Education

Master’s degree

Bachelor’s degree + 2 years PM experience

Associate’s degree + 6 years PM experience

High school diploma + 8 years PM experience

Tools

MS Word

MS Excel

Job description

Amgen is seeking a Sr Associate Project Manager to lead biosimilar program management within the Biosimilars PD/Operation group. You will coordinate technical teams through to regulatory approval, manage ELN/data workflows, and ensure data integrity across LIMS, ELN, and related systems.

The role emphasizes strong organizational and communication skills, collaboration with diverse teams, and adherence to strict data management standards in a fast-paced environment.