Provide leadership and technical contributions to IVD development of new products and assays, including pharma partnerships. Support existing product offerings and contribute to continuous process improvements, within the existing Quality System.
Essential Duties and Responsibilities:
1. Manage the development of new products under Design Controls, including designing and performing Verification and Validation testing, drafting of Design Inputs and Design Outputs, and implementing effective processes for Design Transfer and QC testing.
2. Support the continued production of existing product offerings through continuous improvements in reagent formulations and/or manufacturing processes, sourcing and validation of new raw materials, troubleshooting, and complaint investigations, as needed.
3. Serve as a technical leader for development of Class II and Class III products for 510(k) and PMA submission, including analytical and clinical study designs, protocol drafting and report preparation.
4. Provide internal leadership for companion diagnostic projects with external partners, by establishing project goals and timelines and managing design and development of companion diagnostic kits.
5. Ensure compliance with QSR, ISO 13485, and other external guidelines for development activities.
6. Contribute effectively to risk management activities for new products, including risk analysis and mitigation.
7. Establish a collaborative environment between the R&D, Engineering, Manufacturing, QC, QA and Regulatory teams to support efficient, accurate and compliant development of products.
8. Maintain complete, timely, accurate and legible records.
9. Supervise and/or mentor staff as appropriate.
• Broad knowledge of chemistry, biochemistry, molecular biology, and /or cancer biology.
• Minimum 3 years of experience in IVD product development under Design Controls.
• Familiarity with immunohistochemistry and/or in situ hybridization assays.
• Cross-functional experiencing integrating Manufacturing, QC, QA and RA requirements in the development process.
• Proficiency in Design Control and regulated product development, including FDA 21CFR 820 and ISO 13485 compliant systems.
• Excellent analytical and problem solving skills.
Experience, Education and Certifications:
• BS in applicable field; Ph.D. preferred.
• Demonstrated previous experience and record of publications and presentations.