Job Description

Position Overview

The project Manager is responsible for timeline management, milestone tracking, cross-functional coordination, regulatory readiness planning, and risk management .

Key Responsibilities

1. Project Planning & Execution

· Maintain integrated project plans across cross-functional teams.

· Monitor deliverables and dependencies aligned to product objectives.

· Ensure adherence to development timelines and escalate risks as needed.

· Facilitate cross-functional project meetings and track action items.

· Manage the timeline for CLIA certification and CAP accreditation readiness.

· Coordinate cross-functional activities required for inspection preparedness.

· Align laboratory operational readiness with accreditation and inspection timelines.

2. Risk Management & Communication

· Proactively identify project risks and mitigation strategies.

· Maintain clear communication across stakeholders.

· Serve as central point of coordination for project-level reporting.

Qualifications

· Bachelor’s degree required; PMP or equivalent certification is a plus.

· 3+ years of project or program management experience in biotech, diagnostics, or life sciences 

· Strong organizational and communication skills.

· Experience supporting CLIA/CAP accreditation, LDT development, or regulated laboratory environments preferred.

· Experience supporting clinical development programs in oncology or molecular diagnostics preferred.

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