Global Head Analytical Separation Sciences Vaccines R&D

Are you interested in a new, highly visible global role that allows you to manage a multi located team (5 direct reports based in Belgium, Italy and the US) and an organisation of around 60 scientists while partnering with senior leaders and contributing to the development of a new, global organization with Technology Platform across R&D Centres? If so, this role is an exciting vacancy to explore.

Job Purpose:

Separation and electrophoresis analytical tools are essential to develop candidate vaccines as they assess their quality in terms of safety and potential immunogenicity. These analytical methods are vaccine specific and hence are developed for each new vaccine candidate.

The platform’s accountability starts at the innovation, continues through development, qualification & validation, GMP release testing and ends with the transfer of the analytical methods to commercial QC labs.

Responsibilities:

Strategy and Direction

• Develop and implement best-in-class analytical separation and electrophoresis tools to assess rapidly the potency and quality of candidate vaccines
• Define a phase appropriate strategy covering the early Commit to candidate up to the Launch stage gate for the development and implementation of testing methods of candidate vaccines. This strategy is based on QbD (Quality by Design) principles and aligned with the acceleration initiative.
• Generate data aligned with authorities’ expectations and international guidelines for testing candidate vaccines in clinical phases I, II and III and commercial launch leading to successful CMC file approvals.
• Lead and align practices from the former local ARD centers.

People Management and Development

• Coach and lead analytical team leaders with an enterprise mindset
• Set up an organization with best in class Subject Matter Experts
• Engage with internal stakeholders (Quality, Regulatory, Commercial QC, TDLs, APLs and peer TRD function Heads) to ensure effective collaborations and successful project outcomes

R&D pipeline

• Manage project priorities and foster smart risk taking to allow acceleration of vaccine development

Innovation

• Connect with experts internally in GSK Vaccines and externally with academics to develop state of the art techniques.

External influence

• Influence international guidance by commenting draft versions
• Connect with authorities on specific analytical matters related to submission files

Why You?

Basic Qualifications:

• M.S. or equivalent in Immunology, Biochemistry, Biology Sciences, Virology, or similar.

• 10 years of experience in biologics.
• 5 years of experience in managing people and directing team development activities.
• Working knowledge of FDA / EMA regulatory and GMP requirements.
• Expert knowledge of interpreting analytical requirements for vaccines.

Preferred Qualifications:

• Ph.D. or equivalent in Immunology, Biochemistry, Biology Sciences, Virology, or similar.
• Strong influencing and communication skills with an understanding of the cross-functional facets.
• Remote management experience.
• Problem solving with limited information available to make decisions and interpretations and anticipates medium/long-term future issues.

• Strong interpersonal, organizational, written, and oral communications skills.
• Superlative presentation skills, across lines and levels and with senior stakeholders.
• Ability to manage multiple priorities and senior stakeholders.

• LI-GSK

If 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.

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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