Scientist, R&D Design Transfer & Product Development

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

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 a proven ability to present complex technical data clearly to non-technical audiences

Knowledge of Design Controls, Quality Management Systems (QMS), and regulatory standards (FDA, ISO 13485, CLSI) within GLP/GMP environments is highly desired

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.

As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment.

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: