Associate Director, Nucleic Acid Detection and Quantification Assays and Technologies

Job title:

Associate Director, Nucleic Acid Detection and Quantification Assays and Technologies

Company

GlaxoSmithKline

Job description

Are you looking for a leadership role in analytical sciences that enhances your scientific expertise and allows you to develop best-in-class methods to release and characterize vaccines? If so, this Associate Director role is an ideal opportunity to explore.We are seeking a highly skilled and experienced Associate Director to lead our Nucleic Acid Detection and Quantification Assays and Technologies team. The ideal candidate will possess strong managerial capabilities, a quality control (QC) mindset, and extensive expertise in molecular biology. This role involves leading a team of scientists, overseeing the development and optimization of cutting-edge nucleic acid technologies, and ensuring the highest standards of quality and accuracy in all projects.Within the Global Molecular Analytics Platform, the candidate will be in charge of supervising the execution, implementation, design and development of analytical methods for the detection, identification, characterization and quantification of nucleic acids based on up-to-date nucleic acid technologies (NAT). The analytical methods will span residual nucleic acid quantification (RNA, DNA, pDNA), nucleic acid sizing and structure (topology and conformation), molecular microbiology (e.g. sterility testing and microbial typing), molecular cell biology (e.g. identity, purity and genetic characterization), and molecular virology (e.g. identity, genetic characterization, quantification). The applications cover viral vaccines, polysaccharides-based vaccines, recombinant protein-based vaccines (prokaryotic and eukaryotic expression systems), virus-vectored vaccines and mRNA vaccines.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 NAT-based 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 QC-oriented 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 risk-taking.
• Define a phase-appropriate strategy for the development and implementation of testing methods for candidate vaccines covering the early and late phase development and product launch. Provide strategic direction and oversight for nucleic acid detection and quantification projects.
• 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. 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 cross-functional teams to integrate new technologies and methodologies into ongoing projects.
• Influence project priorities, manage the local portfolio, and encourage smart risk-taking 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 in molecular biology with more than 5 years of experience in the industry (in biologics / biopharmaceuticals / pharmaceutics) or equivalent by experience.
• Proven knowledge of NAT analytical methods (diversity of techniques and technologies) relevant to the role and proven application of said methods preferably to vaccine and/or biological products (viruses [live-attenuated, recombinant, etc.], bacteria, recombinant cell lines [prokaryotic and eukaryotic], RNA, DNA and plasmids).
• 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).
• 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.
• Demonstrate communication skills with external key opinion leaders/experts in specific therapeutic areas or scientific disciplines.
• Demonstrate good judgment and effective decision making in applying expertise to move multiple scientific or technical projects forward.

#Li-GSK #GSKVaccinesIf you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.Why GSK?Uniting science, technology and talent to get ahead of disease together.GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Expected salary

Location

Rixensart, Waals Brabant

Job date

Wed, 25 Sep 2024 02:24:05 GMT

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