Global Director, Vaccine Assay Development (Virology & Bacteriology) in Paris, France

As a Global Director – Vaccine Assay Development , you will be responsible for the development, qualification, validation and troubleshooting of bacterial functional assays (TNA, (M)OPA, SBA, OPK) and viral functional assays (eg. neutralization assays (PRNT, MNT, PNA), hemagglutination assays, plaque assays, etc.) to support vaccine and drug development. The Global Director – Vaccine Assay Development will be supporting all vaccine laboratories (Germany, Canada, USA and China).

RESPONSIBILITIES

• Oversight for development, qualification and validation of immunological assays including but not limited to bacterial functional assays (TNA, (M)OPA, SBA, OPK) and viral functional assays (eg. neutralization assays (PRNT, MNT, PNA), hemagglutination assays, plaque assays, etc.).

• In collaboration with global head of vaccine sciences, define strategy, goals and metrics for the vaccine science team.

• Responsible for strategy implementation for short-/mid-term result.

• Drives innovation and develops new products, processes, standards or operational plans in support of the job function strategy.

• Leads complex technical projects for the organization at a global scale.

• Responsible for ensuring effective resourcing to meet client and budgetary expectations.

• May serve as technical lead and primary point of contact for clients on proposal generation.

• Monitors utilization patterns of services and advise on developing trends in industry needs.

• Provide recommendations to colleagues, senior management, and customers in a timely manner, assisting in project decision-making,

• Participate in the transfer of processes, technology, and assays to/from internal and external collaborators.

• Support Germany, Canada, USA and China scientists to troubleshoot, modify and re-optimize/re-develop current assays.

• Prepare and presents project data and supporting information to internal and external stakeholders.

• Contributes to and reviews technical reports (eg development, qualification, validation plans and reports, etc.).

• Involve in the implementation of the automation strategy to further increase assay throughput and/or improve assay quality.

• Participate in scientific and governance meetings and when applicable, collaborate in original peer-reviewed publications.

• Ensure scheduling associated with R&D activities is aligned with deliverable priorities while keeping in mind project timelines and customer specification.

• Support Business Development on the scientific standpoint including preparation of proposals.

• In collaboration with upper management, define strategy, goals and metrics for the US vaccine sciences team.

• Ensure being up-to-date and compliant related to industry guidance and standards for assay qualification and validation.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Advance knowledge of bacterial functional assays (TNA, (M)OPA, SBA, OPK) and viral functional assays (eg. neutralization assays (PRNT, MNT, PNA), hemagglutination assays, plaque assays, etc.).

• Strong scientific and regulatory requirement knowledge related to method development, transfer, qualification, validation and troubleshooting is required.

• Experience in laboratory automation and liquid handling systems.

• Understanding of applicable regulations (eg GCLP, ICH, etc)

• Understanding of clinical laboratory workflows and acumen for process efficiency and innovation in delivery.

• Demonstrate strong adaptability and flexibility to manage multiple priorities and requests

• Ability to interact with clients, and work to objectives/timelines.

• Excellent attention to details and master communication skills.

• Strong organizational and problem solving skills.

• Ability to maintain clear and efficient documentation as per GDP regulation.

• Proven leadership and management skills

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Minimum MSc with 10 years of industry experience in the development, qualification and validation of regulated immunoassays.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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