Product Development Specialist

3 days ago


Uppsala, Uppsala, Sweden Rarity Bioscience Full time

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.
  • 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, in collaboration with the RA/QA and Product Development manager.
  • 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.

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 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.
  • 3-5 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, 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 6th of February.

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).

#J-18808-Ljbffr

  • Uppsala, Uppsala, Sweden Cytiva Sverige AB - Uppsala Full time

    Job DescriptionDevelop customized bioprocess products in collaboration with cross-functional project teams.Take responsibility for the functionality and quality of products, ensuring regulatory compliance.Work closely with design disciplines to capture customer requirements and implement them into products.Represent the design team during acceptance tests...


  • Uppsala, Uppsala, Sweden Cytiva Sweden AB Full time

    Cytiva Sweden AB, a leader in the life sciences industry, is seeking an experienced System Development Specialist to join our Downstream Systems team. This role plays a crucial part in defining, developing, and implementing hardware and software solutions for our large-scale bioprocess systems.As a System Development Specialist, you will work closely with...

  • Mechanical Engineer

    16 hours ago


    Uppsala, Uppsala, Sweden TN Sweden Full time

    Job OverviewWe are seeking a talented Mechanical Engineer to join our team in Uppsala, Sweden.This role will involve developing hardware requirements and solutions for new products while refining designs for legacy products through coordination and implementing improvements.Prior experience in the development of injection molded parts is...


  • Uppsala, Uppsala, Sweden Cytiva Sverige AB Full time

    Cytiva Sverige AB offers a unique opportunity to join our Product Data Governance team as a Training and Development Specialist. In this role, you will be responsible for developing and implementing effective training programs for Magic PLM application users.About the Job:Develop and maintain digital trainings for Magic User Roles using Articulate 360.Liaise...


  • Uppsala, Uppsala, Sweden Rarity Bioscience Full time

    About This OpportunityRarity Bioscience is seeking a highly motivated and experienced individual to fill the position of Biotech Product Developer. In this role, you will be responsible for developing and verifying the performance of our research-use and diagnostic products.Key Accountabilities:Lead studies to evaluate the performance of our diagnostic...


  • Uppsala, Uppsala, Sweden TN Sweden Full time

    About the RoleThe Senior Manager, Product Quality position is responsible for leading the Product Quality department, which is responsible for performing quality checks on chemicals, raw materials, and products.You will have the opportunity to work on product follow-up and product- and process-related deviation investigations as well as meeting the company's...


  • Uppsala, Uppsala, Sweden Cytiva Full time

    Cytiva is a leading company in the life sciences industry, dedicated to advancing future therapeutics from discovery to delivery. As a Business Analyst, you will be part of the Product Data Management team located in Uppsala, Sweden and the UK.Key Responsibilities:Work with cross-functional teams to define system requirements, implement standard processes,...


  • Uppsala, Uppsala, Sweden People Value Full time

    Company OverviewSenzime is a global medical device company dedicated to safeguarding every patient's journey from anesthesia to recovery. We specialize in precision-based patient monitoring solutions and market an innovative portfolio of products, including the TetraGraph for real-time neuromuscular blockade and recovery monitoring.We foster a culture of...


  • Uppsala, Uppsala, Sweden People Value Full time

    About the JobWe are seeking an experienced System Engineer to join our technology team. As a key member of our team, you will be responsible for leading and participating in the design, documentation, and testing of products.Key ResponsibilitiesDeveloping product specifications and designsCreating and executing verification and validation plansCollaborating...


  • Uppsala, Uppsala, Sweden Knightec AB Full time

    Knightec AB is a company that values innovation, teamwork, and sustainability. As an Embedded Software Engineer, you will have the opportunity to work on exciting projects that make a difference in people's lives. Our team is composed of experts who share your passion for technology and innovation.About the JobThe successful candidate will have a strong...


  • Uppsala, Uppsala, Sweden Danaher Corporation Full time

    Delivering Excellence in Project ManagementWe're looking for a seasoned Senior/Principal Project Manager to join our Resin & Tech R&D department in Uppsala, Sweden. As a key member of our team, you'll be responsible for managing New product development and Sustaining projects for chromatography and related consumables products for protein purification.With a...


  • Uppsala, Uppsala, Sweden TN Sweden Full time

    About UsViedoc is a global leader in life science solutions, empowering pharmaceutical, biotech, and medical device companies to accelerate clinical trials. Our dedication to innovation drives us to push the boundaries of what's possible in clinical research.Job DescriptionCollaborate with cross-functional teams to develop high-quality software...


  • Uppsala, Uppsala, Sweden TN Sweden Full time

    Senior Production Preparation Manager, UppsalaClient:Thermo Fisher ScientificLocation:Uppsala, SwedenJob Category:OtherEU work permit required:YesJob Reference:db851d017a73Job Views:31Posted:23.01.2025Expiry Date:09.03.2025Job Description:Are you interested in a multifaceted role with many interfaces and a lot of responsibility managing projects within a...


  • Uppsala, Uppsala, Sweden Knightec Full time

    About the RoleWe are seeking a talented Embedded Software Engineer to join our team at Knightec. As a consultant in technology, digitalization, and leadership, we work to improve people's lives through game-changing solutions.As an Embedded Software Engineer, you will be working on a wide range of exciting projects that involve developing new products that...


  • Uppsala, Uppsala, Sweden Altris AB Full time

    We are hiring a senior Quality Control Specialist to lead our quality control efforts in ensuring the quality and consistency of our battery cells throughout the manufacturing process.ResponsibilitiesDevelop, implement, and maintain quality control processes and procedures to ensure the highest standards of battery cell production.Lead a team of quality...


  • Uppsala, Uppsala, Sweden TN Sweden Full time

    Company OverviewViedoc is a renowned software company specializing in life science solutions. Our mission is to accelerate clinical trials and support major pharmaceutical, biotech, and medical device companies worldwide.We have offices in Uppsala, Sweden, and other locations globally. Since our inception in 2003, we've empowered over 1 million patients in...


  • Uppsala, Uppsala, Sweden Galderma Full time

    Galderma is the emerging leader in the dermatology market, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology.We are seeking a talented...


  • Uppsala, Uppsala, Sweden Cytiva Sverige AB - Uppsala Full time

    In this role, you'll have the opportunity to leverage your skills and expertise to drive innovation and transformation in the Biotechnology industry. As a Digital Transformation Specialist, you'll work closely with our team to design and develop service platforms and products that improve serviceability, remote diagnosis, and troubleshooting.Key...


  • Uppsala, Uppsala, Sweden Cytiva Sverige AB Full time

    Be part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...


  • Uppsala, Uppsala, Sweden Cytiva Sweden AB Full time

    Be part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...