Project Manager

🔥 13 hours ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $90k - $120k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

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Genomadix

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2021

🧬 Biotechnology

🏥 Healthcare

🔧 Hardware

💰 Corporate round on 2022-09

Biotechnology • Healthcare • Hardware

Genomadix is a company that develops rapid point-of-need pharmacogenetic testing using a compact molecular diagnostic instrument called the Genomadix Cube. Their sample-to-result qPCR platform runs direct PCR from a cheek swab and returns time-critical genotyping results in about one hour; marketed tests include a CYP2C19 genotyping assay for guiding antiplatelet therapy and an APOE test (RUO). Genomadix focuses on precision medicine in acute clinical settings (stroke, acute coronary syndrome) where fast genotype-guided drug selection can change outcomes, and emphasizes alignment with clinical guidelines and on-demand testing to replace multi-day turnaround times.

📋 Description

• Lead medical device projects from R&D development through design transfer and manufacturing transfer • Plan and execute manufacturing transfers with Operations, Quality, Supply Chain, and Regulatory • Partner with R&D to manage development timelines, milestones, and phase-gate reviews • Manage company-wide projects across Quality, Regulatory, Commercial, Customer Success, and Finance • Build and maintain project plans, schedules, budgets, risk registers, and status reports • Coordinate with external partners and suppliers, including Asia-based projects requiring early-morning meetings • Identify risks and dependencies early and drive mitigation and escalation • Ensure project work complies with applicable regulations and standards, including ISO 13485, FDA 21 CFR Part 820, Health Canada, and IVDR • Communicate progress, issues, and decisions to team members and leadership

🎯 Requirements

• Minimum 5 years of project management experience within a medical device PMO environment • Demonstrated experience supporting manufacturing transfers and R&D product development • Experience managing cross-functional projects across a variety of business functions • Working knowledge of design controls, change control, and quality management systems • Proficiency with project management tools and methodologies, including MS Project, Smartsheet, Waterfall, Agile, or hybrid • Strong communication, organizational, and stakeholder management skills • Bachelor's degree in Engineering, Life Sciences, Business, or a related field • Available for regular early-morning meetings to support Asia-based projects • Able to travel occasionally • IVD experience, pharmacogenetics or molecular diagnostics, PMP or equivalent certification, contract manufacturer experience, regulatory submission familiarity, and small/growing company experience are preferred qualifications

🏖️ Benefits

• Full-Time, Permanent employment • Occasional, minimal travel • Remote work arrangement