Related skills
excel ngs doe minitab jmp📋 Description
- Conduct risk assessments (FMEA) to identify gaps and ensure IVD compliance.
- Design and develop manufacturing, QC and commercial processes.
- Plan and execute lab research for scale-up and process capability.
- Lead cross-functional supply chain efforts for raw materials and consumables.
- Attend core team meetings; liaison between R&D and Operations.
- Lead test method developments and validations; set specs.
🎯 Requirements
- Bachelor's degree plus 10 years of relevant experience, or Master's with 7 years, or PhD with 4 years.
- Strong background in molecular biology, biotechnology, or biochemistry.
- Extensive knowledge of design control; GLP/GMP; ISO/CLSI/FDA standards.
- Experience with DOE, Cpk, Gage R&R; and statistical analysis.
- Hands-on experience with NGS, PCR, qPCR, and multiplex PCR.
- IVD product development experience; ability to lead and mentor teams.
🎁 Benefits
- Compensation range: $122,100 — $152,700 USD.
- Total rewards include annual bonus and long-term equity awards.
- Medical, dental, and vision benefits.
- 401(k) with company match.
- Generous PTO and company holidays.
- Wellness and work-life benefits.
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