Biotech Project Manager — Regulatory & Cross-Functional Lead

AccuScan Sciences; Milpitas (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

AccuScan Sciences is seeking an experienced Project Manager to orchestrate cross-functional programs across R&D, operations and regulatory teams. You will maintain integrated project plans, track milestones, and ensure development timelines while escalating risks as needed.

This role supports CLIA certification and CAP readiness, coordinating inspections and ensuring operational readiness in the laboratory environment, with a focus on oncology and diagnostics.

Qualifications

• Bachelor's degree required.
• 3+ years of project or program management experience in biotech, diagnostics, or life sciences.
• Experience with cross-functional milestone tracking and coordinating cross-functional teams.
• Experience working with laboratory operations, regulatory, and quality teams.
• Eligibility to work in the United States required.
• Experience supporting CLIA/CAP accreditation, LDT development, or regulated laboratory environments preferred.
• Experience supporting clinical development programs in oncology or molecular diagnostics preferred.

Responsibilities

• Maintain integrated project plans across cross-functional teams.
• Monitor deliverables and dependencies aligned to product objectives.
• Escalate risks as needed to keep timelines on track.
• 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.
• Proactively identify project risks and mitigation strategies.
• Maintain clear communication across stakeholders.
• Serve as central point of coordination for project-level reporting.

Skills

Project management

Cross-functional coordination

Risk management

Education

Bachelor's degree

PMP or equivalent certification

Job description

AccuScan Sciences is seeking an experienced Project Manager to orchestrate cross-functional programs across R&D, operations and regulatory teams. You will maintain integrated project plans, track milestones, and ensure development timelines while escalating risks as needed.

This role supports CLIA certification and CAP readiness, coordinating inspections and ensuring operational readiness in the laboratory environment, with a focus on oncology and diagnostics.