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The Project Manager will lead cross-functional teams in the design, development, validation, and implementation of diagnostic or research-use assays, while developing and managing detailed project plans, timelines, and budgets. This role also involves ensuring compliance with regulatory requirements and serving as the primary contact for stakeholders.
Position Summary:
- Lead cross-functional project teams in the design, development, validation, and implementation of diagnostic or research-use assays (e.g., molecular, immunoassays, or NGS-based assays).
- Develop and manage detailed project plans, timelines, budgets, and resource allocations to ensure successful and timely project execution.
- Serve as the primary point of contact for internal stakeholders and, where applicable, external partners or collaborators.
- Ensure compliance with regulatory and quality requirements (e.g., IVDR, FDA, ISO 13485) throughout the development process.
- Identify and mitigate project risks, manage changes in scope, and ensure transparency through consistent communication and reporting.
- Facilitate regular project meetings, prepare status updates, and escalate issues to senior leadership when needed.
- Prepare technical documentation, including validation plans, design history files, validation protocols and validation reports.
- Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
- Consistent and predictable attendance is an essential function of the position. Role is remote.
Education Requirements/ Qualification/Experience:
- Master’s degree in Life Sciences, Biotechnology, or a related field; a PhD is a plus.
- At least 2 years of experience in project management of assay development projects, (e.g., Pharma, Biotechnology).
- Strong background in genomics and NGS technologies
- Work experience in a regulated environment/quality management system (e.g. GCLP).
- Proficiency in English is required.
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