About the Role
The Regulated Assay Development group plays a critical role within a regulated life sciences organization, operating at the intersection of science, engineering, and operations to support the development and commercialization of advanced molecular diagnostic products.
We are seeking a flexible, collaborative, and self‑driven scientist with experience designing, executing, analyzing, and interpreting complex, multi‑factorial experiments. Strong troubleshooting skills, critical thinking, and exceptional attention to detail are essential for success in this role.
The ideal candidate will leverage scientific expertise, curiosity, and creativity to collaborate across assay development, reagent manufacturing, and data management teams in a fast‑paced, regulated environment.
What You Will Bring
- B.S. or Ph.D. in Molecular Biology, Biochemistry, Bioengineering, Chemistry, or a related scientific field
- 2+ years of relevant industry or post‑baccalaureate academic experience
- Proven ability to work effectively on cross‑functional teams in a dynamic and evolving environment
- Strong data analysis capabilities with excellent analytical thinking and attention to detail
- Experience with test method validation and/or process validation activities
- Familiarity with regulatory requirements and quality systems applicable to assay development
- Understanding of product development lifecycles and risk management principles
- Hands‑on experience with common molecular biology techniques, including NGS library preparation
- Demonstrated ability to troubleshoot complex technical issues
- Comfort making decisions that influence project direction and timelines
- Ability to communicate complex scientific concepts clearly to technical and non‑technical audiences
- Willingness to work primarily in a laboratory environment as needed to support project deliverables
- Proactive mindset with the ability to learn quickly and adapt to changing priorities
- Experience with data analysis tools or scripting languages (e.g., R or Python) is a plus
What You Will Do
- Design and execute complex, information‑rich experiments to inform development decisions
- Collaborate with cross‑functional stakeholders to support product development deliverables, identify risks, and improve assay performance
- Create and manage timelines related to design transfer and development milestones
- Own and contribute to cross‑functional deliverables such as test method validation and process validation plans, protocols, reports, and risk assessments
- Support root‑cause investigations and implementation of corrective actions related to manufacturing or development issues
- Perform detailed data analyses and apply bioinformatic or analytical pipelines to generate data‑driven recommendations
- Maintain thorough and compliant documentation in alignment with Good Laboratory Practices and Quality System requirements
- Support the transfer of new methods and assays from development into manufacturing and operational environments
- Communicate progress, findings, and recommendations clearly through written documentation and presentations
- Provide technical guidance and mentorship to junior team members as appropriate