Job purpose: As Clinical Assay Expert Scientist - Clinical Functional Immuno Assays, you are an expert in clinical assays within the Clinical Laboratory Science team (CLS), you contribute, to the design of experiments and the interpretation of data required for assay development, validation and maintenance of clinical assays to detect and quantify biomarkers with the support of statisticians.
Under the leadership of a senior scientist your responsibilities will include: Preparation / writing of analytical plans for assay development, qualification and validation steps. Reviewing and interpreting analytical data in collaboration with the designated statisticians. Ensuring the scientific and technical oversight of:
- Internal activities related to assay development and validation, assay maintenance, monitoring and troubleshooting of assay issues and risks, in collaboration with the clinical read-out laboratory.
- External laboratories for assay quality during development, validation, & testing phases.
- Execution of assay analytical plans by the external partner. Ensuring assay history files are properly developed and maintained and assay analytical plans, raw data and statistical reports are stored in sustainable systems and tools Development of team capabilities and the introduction of new concepts to continuously improve assay quality, technical support to projects and cost effectiveness of CLS. Development and maintaining of the expertise in assay technologies to support the technological improvement and innovation in the operational platform with specific attention given to assay quality and testing performance. Ensuring all activities under your responsibility are performed in compliance with Quality Assurance (QA) guidelines, relevant regulations and internal policies Acting as spokesperson, as a technology Scientific Expert on behalf of the CLS organization to internal and external stakeholders (ie. Communication to outsourcing committee, Preclinical teams, collaboration with academic partners, Key Opinion Leaders, ...) Supporting the implementation of continuous improvements of clinical laboratory processes, introduction of state-of-the-art methodologies, innovative solutions and cross-functional team efforts. Participating in CLS and R&D knowledge management in the field of expertise
We are looking for professionals with these required skills to achieve our goals: PhD in sciences or equivalent acquired through professional experience (Biology, Microbiology, Immunology, Biotechnology, Pharmacy orientation). Solid experience (5 years +) in assay development, good Quality culture is key. Scientific expertise in Biology and technology including automation. Good experience in statistics is an advantage. Good knowledge of analytical techniques. Experience in project management. Interest in laboratory work and lab management is an important aspect of this role. Fluent in spoken and written English scientifically/technically as well as conversational are a MUST. Being able to communicate in French or willing to learn are a plus.
If you have the following characteristics it would be a plus: Relevant experience in data interpretation, statistical approaches, etc. Ability to influence and negotiate at all levels of the organization in order to meet objective or deliverable. Good stakeholder management and excellent communication skills are necessary to meet needed mindset and behavioral changes that will be required by the business. Team spirit, autonomy, scientific rigor, analytical mindset & strong networking skills. Good organization skills (day-to-day operations and lab management). Ability to drive change, flexible thinking and having an open mind to imbed change. Continuous scientific curiosity.
calendar_todayil y a 20 heures