Universal DX - Dallas, TX
posted 18 days ago
Full-time - Senior
Remote - Dallas, TX
Ambulatory Health Care Services
About the position
The Sr. Director of Manufacturing, Technology (MSAT) & Supply Chain will play a crucial role in establishing GMP reagent manufacturing capabilities at the Dallas-Fort Worth laboratory. This position involves acting as the liaison between contract manufacturers, laboratory partners, and internal quality control to ensure a consistent supply of reagents for IVD assays. The role encompasses manufacturing, validation, and supply chain management, requiring expertise in reagent manufacturing and the ability to implement scalable manufacturing programs from development to commercialization.
Responsibilities
- Lead, direct and monitor every aspect of reagent manufacturing across in-house and contracted manufacturing sites.
- Ensure production processes are developed, documented, and performed in compliance with company procedures and regulatory requirements.
- Build reagent operations strategy and roadmap including capex, facilities strategy, organization, IT systems, regulatory impact, and business processes.
- Supervise manufacturing planning, scheduling, quality adherence, processing, materials management, and packaging.
- Align production schedules and support activities to meet demand.
- Monitor and optimize production performance through KPIs and foster a culture of continuous improvement.
- Develop and execute business strategies to improve production capability, quality, costs, and customer satisfaction.
- Collaborate with the Assay Development team to facilitate the transition of reagents from bulk to kitted for automation support.
- Ensure compliance with ISO13485 and manage successful audits and recertifications.
- Hire, train, motivate, evaluate, and develop a talented workforce.
Requirements
- Experience in a medical device regulated market, preferably with NGS instrumentation and reagents.
- Knowledge of QSR, CE-IVDR, FDA, ISO13485, ISO14971 regulations.
- Data-driven decision-making through operational metrics and analytics.
- Demonstrated ability to deliver on time and on budget in a fast-paced environment.
- Excellent interpersonal and communication skills to interface with multi-disciplinary teams.
- Willingness to travel 10% domestically.
Nice-to-haves
- Experience with diagnostic systems background other than NGS.
- Familiarity with lean manufacturing principles.
Benefits
- Flexible work schedule
- Remote work opportunities
- Free day on your birthday
- Parking incentive on office locations
- Free cafe amenities on office locations
- Possibility to buy extra vacation days
- Optional health insurance plan
