Product Development Specialist
Rarity Bioscience AB / Kemiingenjörsjobb / Uppsala
2025-01-20
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hela Sverige Visa alla jobb hos Rarity Bioscience AB i Uppsala We are a young, fast-growing company with an agile, cross-functional work environment. We promise you open, respectful, and prestige-free colleagues and a leadership team believing in our ability to grow together. Come and contribute with your experience in product development and make our journey yours.
Your Role
Our products are based on the superRCA technology, which offers ultra-high sensitivity detection of multiple mutation targets simultaneously in liquid biopsies. We have developed mutation targets for both Leukemia as well as solid tumors, and are currently offering standard research kits, custom products, and research analysis services. We are now transitioning from a start-up phase to a scale-up phase and require further focus on verification and validation of our products. You will lead verification studies and analytical performance evaluations, for our research-use and diagnostic products. You will set the requirements, refine and further develop the protocols, and ensure that the documentation is accurate and fit for purpose.
We are a small team, and you will collaborate cross-functionally within the company with the aim of translating research into scalable, market-ready products.
Your main responsibilities will include:
Designing and leading verification and validation studies, including analytical performance evaluations, for research-use and diagnostic products.
Define performance requirements, refine existing protocols and define new, when needed, as well as ensure 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, in collaboration with the RA/QA and Product Development manager.
Assist in areas such as requirement management, change management, and risk management.
In collaboration with statistical expertise and R&D colleagues, evaluate performance studies and reports.
You will report to the Product Development Manager and be part of our core team, playing a critical role in making our liquid biopsy and mutation detection technology accessible to clinicians and researchers. We mentioned that we are on a start-up journey, meaning we adapt quickly, so your tasks may evolve as we grow.
We are located in Uppsala Science Park, where we have gathered all our business functions.
Your Profile
We're looking for a structured, goal-oriented individual committed to making a difference. You should have experience of leading activities, planning effectively, and delivering results independently. We also hope you are a collaborative team player who strives for unified success, 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.
3-5years 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, such as the CLSI guidelines or similar.
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.
Application Join us and be part of a transformative journey in healthcare! We are accepting applications until the 6nd ofFebruary.
If you have any questions regarding the position, please do not hesitate to reach out to Sandra Bydell Sveder, Recruitment Consultant (
sandra.sveder@sallyq.se or 076-319 96 88).
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2025-07-09
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Rarity Bioscience AB (org.nr 559319-9960),
http://www.raritybioscience.com Arbetsplats Rarity Bioscience
Jobbnummer 9112023