Biotech Project Manager: Diagnostics & Regulatory Readiness

AccuScan Sciences; Milpitas (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

AccuScan Sciences in Milpitas, CA, seeks a Project Manager to drive cross-functional programs supporting diagnostic development and operational readiness across scientific, regulatory, and quality teams.

You will maintain integrated plans, manage CLIA and CAP readiness, and coordinate milestones, risks, and reporting to keep programs on track for clinical development in oncology and molecular diagnostics.

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
• Experience with cross-functional milestone tracking and coordinating cross-functional teams required.
• Experience working with laboratory operations, regulatory, and quality teams required.
• 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.
• Ensure adherence to development timelines and escalated 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.
• Proactively identify project risks and mitigation strategies.
• Maintain clear communication across stakeholders.
• Serve as central point of coordination for project-level reporting.

Skills

Cross-functional program management

Regulatory & quality collaboration

Risk identification & mitigation

Project planning & milestone tracking

Education

Bachelor’s degree

Job description

AccuScan Sciences in Milpitas, CA, seeks a Project Manager to drive cross-functional programs supporting diagnostic development and operational readiness across scientific, regulatory, and quality teams.

You will maintain integrated plans, manage CLIA and CAP readiness, and coordinate milestones, risks, and reporting to keep programs on track for clinical development in oncology and molecular diagnostics.