Senior Scientist, R&D Design Transfer & Product Development
Position Summary
The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from Research and Development (R&D) to Operations. This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work, data analysis, and documentation. As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment.
Primary Responsibilities
Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports
Test Method Development: Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications
Quality & Risk Management: Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR)
Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products
CAPA & Troubleshooting: Investigate product or process deviations, perform root cause analysis, and implement Corrective and Preventive Actions (CAPA)
Cross-Functional Collaboration: Partner with Supply Chain to establish raw material and consumable pipelines; present status updates, data, and technical proposals to cross-functional stakeholders
Qualifications
Molecular Biology Experience: Hands-on expertise in Next-Generation Sequencing (NGS) workflows such as DNA/RNA extraction, targeted enrichment, or whole genome library preparation and/or deep expertise with other DNA molecular biology techniques such as PCR, qPCR and multiplex PCR
Experimental & Analytical Skills: Ability to own a study from start to finish including designing experiments, executing in the lab, analyzing data and documenting results. Must be able to perform basic statistical analysis
Communication: Excellent cross-functional communication and interpersonal skills, with a proven ability to present complex technical data clearly to non-technical audiences
Execution: Exceptional time management and organizational skills, with a demonstrated ability to balance multiple priorities and drive deliverables to completion
Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments is highly desired
Experience authoring study plans, protocols and study reports is highly desired
Experience with statistical software (such as JMP) is highly desired
Prior experience in IVD product development or commercialization is preferred
Experience in manufacturing, scale up, and Quality Control (QC) is preferred
Experience with automated liquid handling platforms (e.g., Hamilton, Tecan) is preferred
Benefits
Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents
Pregnancy and baby bonding leave
401(k) benefits
Commuter benefits
Free testing and fertility care benefits
Employee referral program
Pay Range
The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location.