Senior Associate Project Manager

🔥 18 hours ago

🇺🇸 United States – Remote

💵 $89.2k - $120.6k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide project management to technical teams developing biosimilar candidates through regulatory approval • Manage biosimilar business unit analytical similarity sample management • Collaborate with Similarity Team, Critical Regents Group, Data Management, and scientific staff to plan and maintain inventory • Manage sample distribution logistics for testing and communicate incoming data • Create electronic laboratory notebooks (ELN) for sample submission • Generate lot numbers and sample IDs and retrieve data in QC LIMS • Assist staff with navigating ELN software and placing work orders for ELN updates • Query LIMS, ELN, and other databases; compile and organize data for review and verification • Retrieve and organize data for review with Data Management • Archive documents in a controlled document repository • Verify data for internal documents and regulatory filings in a controlled document system • Review regulatory documents and determine data elements requiring verification according to established protocols • Collaborate with cross-functional teams to complete accurate data verification processes • Format documents according to Amgen’s internal style guidelines and standards

🎯 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 • 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 • 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 • Sponsorship for this role is not guaranteed

🏖️ 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 • 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 • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support