Overview As Staff Manufacturing Scientist, you lead multi-site consumable manufacturing and process-improvement efforts to add value and meet cost, quality, and delivery goals. You collaborate with internal customers and cross-functional teams to define requirements, assess risks, and drive verification, validation, and design transfers in a GMP environment. You guide design changes for technical processes and equipment, enabling scalable, compliant, and efficient manufacturing in the life sciences diagnostics space.
Compensation / Benefits- comprehensive benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
- bonus/incentive pay
Responsibilities- Identify consumable design and process improvements to support business growth
- Collaborate cross-functionally to define user requirements, perform risk analysis, and prepare verification/validation plans and reports
- Execute design transfers for medical device-related processes and equipment
- Lead teams through design changes for technical processes or equipment improvements
Key requirements- Bachelor in Biology with 9+ years of relevant experience, or Master in a related field with 7+ years, or Doctoral degree with 4+ years
- Design control: change control, risk management, design requirements, design validation & verification, design transfer
- Project management experience
- GMP experience
- cross-functional collaboration
- leadership
- clear communication
- design control processes
- risk management
- design validation & verification
