
Product Development Lead
6 days ago
Company Overview
Rarity Bioscience is a rapidly growing company with a strong focus on innovation and research.
We are developing cutting-edge products based on superRCA technology, which enables ultra-high sensitivity detection of multiple mutation targets simultaneously in liquid biopsies.
Your Role
You will lead verification studies and analytical performance evaluations for our research-use and diagnostic products.
This includes designing and refining protocols, ensuring accurate documentation, and collaborating cross-functionally within the company to translate research into scalable, market-ready products.
Main Responsibilities
- Designing and leading verification and validation studies, including analytical performance evaluations, for research-use and diagnostic products.
- Defining performance requirements, refining existing protocols, and defining new ones when needed, as well as ensuring that the documentation is accurate and fit for purpose.
- Preparing documentation to support in vitro diagnostic device (IVD) registration in compliance with applicable regulations and guidelines.
- Assisting in areas such as requirement management, change management, and risk management.
- In collaboration with statistical expertise and R&D colleagues, evaluating performance studies and reports.
Your Profile
We're looking for a highly structured and goal-oriented individual committed to making a difference.
You should have experience leading activities, planning effectively, and delivering results independently.
Collaboration and a team player mindset are essential, but most importantly, we hope you are yourself. We are a team of individuals, and our differences are what make us a dream team.
Qualifications
- A university degree in Molecular/Cell Biology, Biotechnology, Biochemistry, or a related field.
- 3-5 years of experience in product development, particularly in verification and validation within a regulated environment.
- Proficiency in report writing and familiarity with statistical methods and data analysis.
- Experience collaborating with statistical experts and designing performance studies according to standards and guidelines.
- Professional fluency in English, both written and verbal.
Experience from flow cytometry and molecular biology techniques, including PCR and other DNA amplification methods is a plus.
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