Mark Campion
Program Manager | Product Development | Biotechnology | Medical Devices | SAFe | Agile | Full Life Cycle Management | Design Controls
- Role
- Associate Director, Ivd Program Management at Akoya Biosciences, Inc
- Location
- Tucson, AZ, US
- LinkedIn followers
- 500 followers
About Mark Campion
I’m passionate about turning breakthrough science into accessible healthcare solutions…
Experience
Associate Director, Ivd Program Management
Oct 2022 — Present · US
Led cross-functional team in developing a multiplex companion diagnostic (CDx) and digital pathology software (SaMD) to support patient selection in immuno-oncology. Directed program planning, risk management, and vendor coordination across multiple workstreams. Oversaw GMP manufacturing readiness, software workflow prototyping, and stakeholder engagement. Presented program status at phase-gate reviews and aligned budgets and forecasts with strategic priorities. Supported quality and process improvement initiatives to strengthen development execution and ensure operational readiness.
Skills
- Scrum
- Genomics
- Product Management
- Molecular Biology
- Hardware Diagnostics
- Biotechnology
- Agile & Waterfall Methodologies
- Six Sigma
- Biopharmaceuticals
- Cross Functional Team Building
- Manufacturing
- Validation
- Leadership
- Program Management
- Automation
- Pharmaceutical Industry
- Fda
- Biomedical Engineering
- Medical Devices
- R&D
- Process Improvement
- Project Management
- Iso 13485
- Strategic Planning
- Commercialization
- Life Sciences
- Lifesciences
- Cross-Functional Team Leadership
- Accelerated Life Testing
- Product Development
- Technology Transfer
- Functional Verification
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