Senior Associate Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee project management for technical teams working on biosimilar candidates until they receive regulatory approval.

• Supervise the analytical similarity sample management within the biosimilar business unit.

• Collaborate with the Similarity Team, Critical Regents Group, Data Management, and scientific personnel to organize and sustain inventory.

• Manage the logistics of sample distribution for testing and communicate incoming data effectively.

• Create electronic laboratory notebooks (ELN) for the submission of samples.

• Generate lot numbers and sample IDs while retrieving data from QC LIMS.

• Assist team members with ELN software navigation and facilitate work orders for ELN updates.

• Query LIMS, ELN, and other databases to compile and arrange data for review and verification.

• Collect and organize data for examination with Data Management.

• Archive documents systematically in a controlled document repository.

• Confirm data accuracy for internal documents and regulatory submissions within a controlled document system.

• Review regulatory documents and identify data elements that need verification according to established protocols.

• Work collaboratively with cross-functional teams to ensure precise data verification processes.

• Format documents in accordance with Amgen’s internal style guidelines and standards.

⛳️ Requirements

• Master’s degree OR a Bachelor’s degree with 2 years of Project Management experience OR an Associate’s degree with 6 years of Project Management experience OR a High school diploma/GED accompanied by 8 years of Project Management experience.

• Experience in supporting pharmaceutical research and development or nonclinical drug development programs within the biotechnology, pharmaceutical, or life sciences sectors.

• Proficiency in working with document management systems, collaboration platforms, and project management tools.

• Background in coordinating scientific or regulatory documents throughout their lifecycle.

• Exceptional organizational skills with the capability to manage multiple priorities in a fast-paced, dynamic environment.

• Strong analytical skills are required.

• Proficiency in MS Word and MS Excel is necessary.

• Knowledge of good data practices and data verification is essential.

• Understanding of systems designed for sharing and collaboration.

• Excellent communication skills are a must.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan with generous company contributions, along with group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.

• Participation in a discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans and bi-annual company-wide shutdowns.

• Flexible work models, including remote and hybrid work options where feasible.

• Opportunities for career development.

• Financial plans that support saving towards retirement or other goals.

• Work/life balance support.