We are looking for a Senior Assay Developer with a strong technical background in development of IVD assays, for the development of a radically innovative testing solution for airborne infectious diseases, such as SARS-CoV-2. Experience with PCR technology and a hands-on track record in assay development up to product development are required. Your experience includes molecular biology methods, protein characterization and purification techniques, GLP and design controlled development. Your main background lies in the mature phase of the development, including industrialization.
Each system includes multiple components, from electronics (camera boards, image sensors) to opto-mechanics (lenses, shutter, piezo-electric components, robotics) and all those must be fully integrated including mechanics and software. You will interact with different technical experts and drive the development forward through refinement of requirements and specs. You will help define and execute the path towards the total solution: evaluate sub-components, select and qualify suppliers, plan assembly & testing with subcontractors and suppliers. You will work closely with the project manager and bridge towards the optical/mechanical/instrumental engineers. Your overall view will link the components to the product, as such ensuring full system requirements are met.
•Develop state of the art IVD assay, with a focus on verification and product introduction.
•Work according to GLP practices.
•Experience with generation of Product Design History File and Design Change, Procedure is a plus.
•Monitor the interdependencies between components; continually assess critical specs; proactively anticipate risks and bottlenecks.
•Work with technical owners to review project contributions and risks and formulate recommendations for customers and management.
•Manage time effectively according to aggressive project schedules.
•Quickly adapt to new project requirements and effectively manage change requests.
Required knowledge and skills
•Master or PhD in biotechnology, biosciences or similar;
•You have experience in people and project coordination in a high-tech environment;
•At least 5 years of relevant experience in leading medical systems design or IVD product development;
•You are knowledgeable in PCR or immuno technology and applications;
•You have experience in a prototyping and problem solving in product development environment with an interdisciplinary team.
•You are a team player with excellent communication skills and fluent in English.
Tormans invests in your future by offering appropriate training, personal guidance during the execution of your projects, advice and customized coaching.
Our projects are located at the most important (inter)national companies in various sectors, which means you will be introduced to the most modern techniques and the most diverse installations so that you can develop your knowledge and talent to the fullest.
In addition to an open-ended contract with an attractive, tailor-made salary, we offer numerous extra-legal benefits, including meal vouchers, a daily allowance, company car, hospitalisation insurance,...
At Tormans you can count on a professional, personal and honest no-nonsense approach.