Principal Scientist/IVD Manager - IVD/CDx Assay Development
The Principal Scientist/ Technical Project Manager - IVD/CDx Assay Development is key member of a rapidly growing Diagnostics team. He/she is responsible for developing, executing, and critical evaluation of experimental designs in support of clinically oriented products intended for regulatory submission. He/She will work closely with R&D, Quality, Regulatory, Clinical Development, Production teams and external pharma partner to translate laboratory processes from feasibility to validated assay. Additionally, they will work closely with the Marketing, Medical, Clinical, and Quality Teams on document drafting, revising, and approval. The successful candidate will have strong leadership and multi-disciplinary skills including expertise in biochemistry/molecular biology, technology, analytical validation including study design and interpretation of data, and excellent written and oral communication.
- Manage and oversee a technical team in full implementation and execution of programs with external and internal collaborators within the accepted timelines, budgets and resources
- Oversee overall product development planning and implementation strategy for Diagnostic product(s)
- Develop verification and validation protocols under Design Control
- Manage and oversee a technical team in execution of verification and validation studies
- Oversee the study data analysis and study report writing
- Participate in cross-functional teams (including bioinformatics, software, clinical development, manufacturing, quality and regulatory)
- Participate in the planning, writing and implementation of laboratory focused clinical trials and collaborative studies.
- Serve as a liaison to Technical, Clinical Development and Operations for clinical biomarker validation activities
- Draft technical regulatory documents for regulatory applications
- Develop status reports for Executive Team and external collaborators
- Publish scientific results
- Other duties as assigned
EXPERIENCE AND QUALIFICATIONS:
The successful candidate will have an advanced degree in molecular biology, biochemistry, bioengineering or related field, and experience with
- Design control, verification and validation of FDA-regulated products.
- Proficiency in NGS, PCR, qPCR, and sample prep techniques
- Experience writing protocols, reports, pre-submissions, IDE and other PMA submission related documentation for molecular diagnostic applications
- Minimum of 8-10 years' experience in the diagnostic or pharmaceutical industry
- Knowledge of principles of quality control and quality assurance
- Proven ability to coordinate multifaceted projects, including multitasking, deliverables management and timeline management
- Strong regulatory experience with the FDA
- Experience growing a team to meet company growth objectives preferred.
- Driven, self-starter who is comfortable in a fast-paced start-up environment
- Effective leadership and communication skills
- Able to organize and prioritize diverse responsibilities to achieve company goals
- Demonstrates strong leadership capabilities with the ability to lead multiple projects through a complex development program
- Handles tight timelines and stress in a constructive manner
- High attention to detail, with the ability to create clear and concise technical documentation.
- MS/PhD in biology, molecular biology, biochemistry or related field