Sr Associate Project Manager
New
A
AmgenBiotechnology
United StatesFull-TimeSenior
SalaryUSD 89168.4 - 120639.6 / year
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Job Details
- Experience
- Master’s degree OR Bachelor’s degree and 2 years OR Associate’s degree and 6 years OR High school diploma / GED and 8 years
- Required Skills
- Project ManagementMicrosoft ExcelAnalytical Skills
Requirements
- Master’s degree, or Bachelor’s degree with 2 years of project management experience, or Associate’s degree with 6 years, or High school diploma/GED with 8 years of project management experience.
- Strong analytical skills.
- Strong proficiency in MS Word and MS Excel.
- Knowledge of good data practices and data verification.
- Understanding of systems for sharing and collaboration.
- Excellent communication skills.
- Experience supporting pharmaceutical R&D or nonclinical drug development programs preferred.
- Experience with document management systems, collaboration platforms, and project management tools preferred.
- Experience coordinating scientific or regulatory documents throughout the document lifecycle preferred.
- Strong organizational skills with the ability to manage multiple priorities in a dynamic environment.
Responsibilities
- Provide project management to technical teams responsible for developing biosimilar candidates through to regulatory approval.
- Manage biosimilar business unit (BBU) analytical similarity sample management and maintain sample inventory.
- Manage logistics for sample distribution for testing and facilitate incoming data communication.
- Create and manage electronic laboratory notebooks (ELN) for sample submission.
- Generate lot numbers, sample IDs, and retrieve data in QC LIMS.
- Perform database queries of LIMS, ELN, and other systems to compile and organize data for independent review.
- Document archival in controlled document repositories.
- Provide data verification for internal documents and regulatory filings in accordance with established protocols.
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