Senior Scientist, R&D Design Transfer & Product Development

The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from 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.

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

Requirements

PhD in Molecular Biology, Cell Biology, Biotechnology, Biochemistry, or a related scientific field with 4+ years of relevant industry experience; OR Master's degree in the fields above with 7+ years of relevant industry experience; OR Bachelor's degree in the fields above with 10+ years of relevant industry 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; 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; Excellent cross-functional communication and interpersonal skills, with proven ability to present complex technical data clearly to non-technical audiences; Exceptional time management and organizational skills, with demonstrated ability to balance multiple priorities and drive deliverables to completion

Nice to have

Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments; Experience authoring study plans, protocols and study reports; Experience with statistical software (such as JMP); Prior experience in IVD product development or commercialization; Experience in manufacturing, scale up, and Quality Control (QC); Experience with automated liquid handling platforms (e.g., Hamilton, Tecan)

Benefits

Comprehensive medical, dental, vision, life and disability plans; free testing for employees and their immediate families; fertility care benefits; pregnancy and baby bonding leave; 401k benefits; commuter benefits; employee referral program