2 дня назад
Sr Associate Project Manager (Biosimilars)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr Associate Project Manager (Biosimilars): Managing analytical similarity sample workflows and data verification for biosimilar programs progressing toward regulatory approval with an accent on sample logistics, LIMS and ELN systems, and controlled documentation. Focus on coordinating cross-functional scientific teams, organizing data for review, and ensuring accurate regulatory filing support.
Location: Remote role associated with Washington, D.C., United States; U.S. location indicated, excluding Puerto Rico
Company
is a biotechnology company developing, manufacturing, and delivering medicines for serious diseases, including biosimilar programs.
What you will do
- Manage technical projects and analytical similarity sample workflows for biosimilar programs through regulatory approval.
- Coordinate sample inventory, logistics, testing distribution, and incoming project data.
- Create electronic laboratory notebooks and manage sample IDs, lot numbers, work orders, and data retrieval in QC LIMS.
- Compile, organize, archive, and independently verify data in collaboration with Data Management and scientific teams.
- Support regulatory document verification and formatting according to internal standards.
Requirements
- Master’s degree, or a bachelor’s degree plus 2 years of project management experience, or an equivalent combination of education and experience.
- Strong analytical, organizational, communication, Microsoft Word, and Microsoft Excel skills.
- Knowledge of good data practices, data verification, collaboration systems, and document management.
- Ability to manage multiple priorities in a dynamic environment and coordinate cross-functional teams.
- Experience in pharmaceutical research, biotechnology, pharmaceutical, or life sciences environments is preferred.
Culture & Benefits
- Comprehensive health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Annual bonus program and stock-based long-term incentives.
- Paid time off plans and company-wide shutdowns.
- Flexible work models, including remote and hybrid arrangements where possible.
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