Laboratory Scientist

Cambridge, UK

Who we are

PredictImmune’s mission is to help people with chronic autoimmune diseases live normal and healthy lives. Our flagship product is PredictSURE-IBD, a novel IVD that identifies patients at higher risk of developing severe relapsing-remitting Inflammatory Bowel Disease (Crohn’s Disease and Ulcerative Colitis). Our technology is the result of over 15 years’ research at the University of Cambridge, and the insights we generate guide personalised treatment decisions to ensure the best outcome for each individual. We are a global company headquartered in the UK, with partnerships in the EU and North America.

The Role

We are seeking a Laboratory Scientist to join our team. You will work under the direction of the Product Operations Manager and support the day-to-day running of PredictImmune’s laboratory, including product management activities in accordance with QMS (ISO13485:2016) and regulatory requirements (2017/746 EU IVDR, UKCA Mark). You will participate in a programme of assay development to continuously improve the IVD tests developed by the company and support training and development of existing and new laboratory users of PredictImmune’s IVD tests.

Your Key Responsibilities

• Undertake product inspection and batch QC testing of IVD test product, in accordance with release for sale procedures
• Support the product stability monitoring programme to include execution of testing, data analysis/ interpretation, completion of required documentation and communication of results.
• Support product distribution activities to multiple international sites
• Participate in product-related troubleshooting activities.
• Support reagent and consumable supply management and placing orders as appropriate
• Support day-to-day safety of operation, maintenance and cleanliness of the laboratory environment and equipment
• Participate in risk management and post-market surveillance activities.
• Collect, collate and evaluate scientific data from a range of sources.
• Support regulatory/customer inspections and with notified body technical file enquiries.
• Participate in quality assurance procedures, including incident management & CAPA, change controls.
• Work in accordance with the Standard Operating Procedures developed for use in the Company.
• Abide by all Codes of Practice, Safety Regulations, statutory requirements and operational policies of the company

    Who you are

    You thrive on recognising, analysing and solving complex problems in a methodical manner. You are well-organised, self-driven and have proven ability to prioritise, work under pressure. You can manage multiple projects with a sense of urgency. You have excellent verbal and written communication skills and adhere to quality and regulatory standards in a methodical and detailed manner. You can work independently and within a team setting and bring a positive and collaborative attitude to our small but growing team. You are a self-starter with strong interpersonal skills who knows when to lead, when to follow, and when to ask for help.

    Your Qualifications

    • MSc life sciences degree or equivalent experience
    • At least 1 years’ experience in a R&D and/or Manufacturing environment
    • RNA handling and RT-qPCR experience.
    • Broad knowledge of molecular biology techniques
    • Understanding of ISO13485:2016 and associated standards (e.g., ISO 14971; EN 62304)
    • Good working knowledge of standard Microsoft packages

    The following additional experiences & skills would also be helpful:

    • Past experience working in an IVD industry-based role
    • Experience of working within an ISO13485, QMP or similar regulated environment.
    • Effective project management skills.
    • Working knowledge of statistical tools (e.g. JMP)
    • Good understanding on laboratory safety
    • Up to date knowledge of IVD regulatory pathway in UK, EU and US

    What you’ll get in return

    You will work, learn and grow alongside a group of dedicated professionals who are passionate about what they do and why they do it. You will have the opportunity develop hard and soft skills in a fast-paced start-up environment while receiving a competitive salary and benefits package including private medical insurance, life insurance and a generous pension scheme.

    We are located on the prestigious Babraham Research Campus, which offers a cafeteria serving coffees and hot and cold food where you can meet professionals from over 60 companies. The campus has beautiful grounds, tennis courts and 430 acres of parkland for lunchtime walks.

    If you feel you’ve got what it takes to join our vibrant and dynamic company, we would love to hear from you. Please send your CV and covering letter to: careers@predictimmune.com mentioning our reference: JOB-2022-02 in the subject line.

    NO AGENCIES PLEASE

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