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Associate Director Nucleic Acid Detection and

Il y a 4 mois

Rixensart, Wallonie, Belgique GSK Temps plein

Site Name:
Belgium-Rixensart

Posted Date:
Jun 7 2024

  • Are you looking for a leadership role in analytical sciences that enhances your scientific expertise and allows you to develop bestinclass methods to release and characterize vaccines? If so, this Associate Director role is an ideal opportunity to explore._
  • The hired Associate Director is expected to manage a group of +/ 10 Technicians, Associate Scientists, Scientists and Expert Scientists designing and executing scientific studies using NATbased analytical methods in support of technical development programs as they progress from early development into Phase I/ II, Phase III, technology transfer and process performance qualification at the intended commercial site according to Quality by Design principles and in partnership with other Technical Research and Development functions, as well as the Quality and Regulatory Departments. A strong QCoriented mindset is expected._

Your responsibilities:

This role will provide you the opportunity to lead key activities to progress your career.

These responsibilities include some of the following:

  • Strategy, Leadership and Management:
  • Contribute to the growth of a Global Molecular Analytics team by aligning on global priorities and portfolio management, harmonizing technical capabilities, development approaches, documentation, resource constraints, and appropriate risktaking.
  • Identify risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team.
  • Lead and manage a team of scientists and researchers, fostering a collaborative and innovative work environment.
  • Provide strategic direction and oversight for nucleic acid detection and quantification projects.
  • Mentor and develop team members, ensuring continuous improvement and professional growth.
  • Perform a leadership role for safety, regulatory, compliance or data integrity on behalf of GSK.
  • Research and Development:
  • Drive the development, validation, and optimization of nucleic acid detection and quantification assays and technologies based on QbD principles.
  • Oversee the design and execution of experiments, ensuring robust and reproducible results.
  • Collaborate with crossfunctional teams to integrate new technologies and methodologies into ongoing projects.
  • Influence project priorities, manage the local portfolio, and encourage smart risktaking to accelerate vaccine development
  • Quality Control and Compliance:
  • Implement and maintain stringent quality control measures across all stages of assay development and deployment.
  • Ensure compliance with industry standards, regulatory requirements, and company policies.
  • Conduct regular audits and reviews to identify areas for improvement and implement corrective actions.
  • Project Management:
  • Manage multiple projects simultaneously, ensuring timely completion and alignment with company goals.
  • Develop project plans, allocate resources, and track progress against milestones and deliverables.
  • Communicate project status, challenges, and outcomes to senior management and stakeholders.
  • Innovation and Continuous Improvement:
  • Stay abreast of the latest advancements in nucleic acid detection and quantification technologies.
  • Identify and evaluate emerging trends and technologies for potential integration into the company's portfolio.
  • Foster a culture of innovation and continuous improvement within the team.

_ Why you?_

Basic Qualifications:

  • We are looking for professionals with these required skills to achieve our goals:_
  • PhD degree (biotechnology, molecular biology, biochemistry, (molecular) bacteriology, (molecular) microbiology,) with more than 5 years of experience in the industry (in biologics / biopharmaceuticals / pharmaceutics) or equivalent by experience.
  • Experience/knowledge about method transfer to QC, answers to Regulatory Agencies questions, use of NAT data for file submissions.
  • Languages: fluent in French and English (spoken and written). Fluent English knowledge is a must (collaboration in international environment, conferences, etc).
  • Good organizational skills.
  • Team work. Efficiently interacts with line management and other Associate Directors.
  • People management, coaching, communication, innovation oriented, synthesis and analytical capacity, presentation skills, influencing, flexibility.

Preferred Qualifications:

  • If you have the following characteristics it would be a plus:_
  • A strong background in molecular microbiology.
  • Expert knowledge in QPCR assays, direct nucleic acid detection techniques, nucleic acid separation by different electrophoresis techniques, molecular cell biology, microbiology.
  • Ability to work within a diversity of cultures and teams located in different time zones.
  • Good understanding of Computerized-System Validation, ALCOA-CCEA principles, and GMP requirements.
  • Dem