On Market Support Scientist

Job Purpose 

The role will support the range of IDS CLIA endocrinology products currently in the market.  The role will focus on leading scientific investigations, validations and implementations of fixes to on market products.

Additionally, the role will work closely with QA, Operations, R&D and Technical Support teams to resolve customer complaints or drive improvement opportunities related to these on market products. They will be the key scientific lead related to such issues and will be responsible for driving fix / improvement projects to conclusion working cross functionally as required.

Principal Accountabilities 

• Conduct investigation and validation projects to resolve customer and internal complaints related to on-market assays.

• Define project scope with project sponsor.

• Manage the timelines for all activities, and for project tasks until project end (Design and development plan and detailed project plan, status reports) ensuring all projects are delivered to agreed timescales.

• Manage R&D laboratory and department activities (share with other Liege staff) • Perform risk assessment for any proposed fixes

• Respect Quality assurance and regulatory aspects

• Communicate effectively and ensure project follow up with the project team

OMS Scientist’s tasks and deliverables: 

• Key scientific lead to facilitate solution to on-market assay issues

• First point of scientific contact for Technical Support and Product Management teams in event of on-market assay issues.

• Introduce fixes/solutions to improve on-market assay performance

• Conduct root cause investigations on on-market and prototype assays

• Assay analytical performances establishment according to the CLSI guidelines

• SOPs writing together with the functional experts assigned to the project team

• Verification and validation protocols and reports writing

• Transfer to the operations team any agreed fixes / improvements

• Supervise on time availability of materials and reagents, especially appropriate samples

• Provide technical support for assay improvement projects.

Project management 

• Elaborate and implement work breakdown structure and tasks for the detailed project plan and manage project cross functionally.  • Lead cross-functional project team, continuously define and get the knowledge and functional contributions from Product Manager, Core Tech, ASI, VAS/QC, manufacturing, RA, QA, Project Manager • Plan, execute and supervise all project development tasks covered by the project plan • Elaborate, complete and communicate project documentation compliant with regulations (including protocols, reports, Design History File and Technical File) • Prepare, document and follow up design review and project milestones • Contribute to the preparation of documents for regulatory purposes • Deliver project commitments for and between milestones

Team management 

• Lead, motivate, inform and integrate project team, staff, and partners • Quickly and efficiently reolve conflicts to keep the projects on target • Retain strong working relationships with the team and across sites

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Job Description – On Market Support Scientist

 Skills, Knowledge, and Experience 

Qualifications 

 • Master degree in Science, Ph.D. is preferred

• 5+ years relevant related professional experience ideally gained within immunoassay development for automated systems across various disciplines

• Experience leading cross-functional teams

• Strong and proven experiences in project management

• Fluent in English and French

• Comprehensive knowledge of relevant biochemical methods and technologies

• Competent regulatory knowledge related to IVD design change.

Skills & Knowledge 

• Thorough knowledge of immunoassay design

• Proven capability to manage scientific projects to agreed deadlines

• Ability to perform root-cause investigations of on market immunoassay issues

• Excellent communication skills, negotiation skills and conflict management skills

• Proficiency utilizing MS Office tools and portfolio/project management SW solutions

• Build efficient and strong relationships with business project stakeholders, and project portfolio stakeholders, functions and project leaders/teams

• Strong collaborator who can work efficiently with other in matrix environment, knows how to use formal and informal networks to drive timely and measurable results

• Ability to influence with and without authority

• High cultural awareness and proven ability to work with a wide range of cultures

Cultural Aspects – IDS Values

Passion for Customers – We are passionate in understanding our customer needs and dedicated to providing excellent solutions

Entrepreneurial – We consider the world around us as a set of opportunities, creating the chance to innovate and find solutions to generate customer and stakeholder value

Excellence – We strive for excellence in all we do, to deliver the best results in order to be best in class!

Respect – We show consideration for colleagues, customers and all business stakeholders, appreciating our diversity and respecting each other’s opinions

Job Role On Market Support Scientist
Job Department Research and Development
Job Region Belgium - Liege
Job Country Belgium