Vaccines Molecule Stewards Head

Description

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Global Supply Chain network, site goals and objectives are achieved, through a focused strategy execution.

MSAT is the keeper of the body of knowledge associated with the formulation, device components, analytical testing and manufacturing unit operations, creating the instruction set and ensuring manufacturing operations stay aligned with the registered process, with the primary objective being to ensure manufacturing processes are capable, compliant, in control, continuously improved to be performant and cost-efficient, remain state of the art and aligned across Sites.

MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, provide process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related improvement programs within the GSK GSC perimeter.

The Molecule Stewards are the single point of end-to-end accountability for a given molecule, trough the lifecycle, from development to late lifecycle, for products developed and manufactured internally and externally to GSK.

The Vaccines (Vx) Molecules Stewards are aligned to a new Vx asset as of C2Ph1/2 with responsibility for representing MSAT in the development of the Product Control Strategy. When the product transfers to GSC accountability, the Molecule Steward co-ordinates Drug Substance, Drug Product, Analytical Strategy and if appropriate Device Leads to maintain the Product Control Strategy and ensure the product is maintained in the desired state of control through product lifecycle.

Job purpose:

As Vaccines Molecule Steward Head, you

Have management responsibility for a team of Vx Molecule Stewards, setting the standard for the role and ensuring molecule stewards meet the expectations and requirements for the role.

Lead the definition and deployment of key technical strategies in support of the new product pipeline and key brand portfolio, ensuring this covers industrialization and late lifecycle to meet the needs of the business.

Are member of the MSAT Molecule Steward Leadership Team covering Vx and Medicines. and will need to operate at an enterprise level on behalf of the MSAT organization.

Are a key point of contact within the MSAT organization for CMC or key projects pertaining to Vx new product pipeline & commercial assets, connecting with other teams in MSAT to ensure the appropriate SME/specialist support is secured and engaged. 

Are expected to act as a molecule steward for one product and/or lead enterprise projects.

Your responsibilities:

Lead a team of Molecule Stewards, setting the standard for the role, ensuring other molecule stewards in the team meet the expectations and requirements for the role.

Direct and lead the definition and deployment of key technical strategies in support of the new product pipeline and key brand portfolio, ensuring this covers industrialisation and late lifecycle to meet the needs of the business.

Deliver right first time PQ/validation for new product introduction, ensuring robust control strategies are developed and in place across the portfolio of products. This extends across the late lifecycle for key commercial brands and Vx as improvements and 2nd generation changes are industrialised.

Lead and provide input and direction to the CMC development pipeline, support CMC teams to deliver product development plans and ensure we are challenging current working practices.

Contribute to definition and implement the required digital improvement projects to enhance our product knowledge capability and robustness of product portfolio through digital twins and management of digital process data.

Drive rapid resolution of product technical issues, working across MSAT and enterprise functions to secure global expert support, as required. Leads on complex technical troubleshooting and continuous improvement on CAPA effectiveness.

Establish and lead a defined performance management structure to drive improvement in areas such as delivery of product control strategies and key development milestones, product robustness improvements and performance [e.g. productivity / CoW / PPV initiatives] including technical team capability build.

Ensure learnings from Vx portfolio are deployed to enhance the robustness of the new product pipeline and our key brand portfolio, across Vx and medicines.

Maintain an active technical talent management and succession programme for the Vx Molecule Steward team, connecting across the wider MSAT team, GSC and R&D.

Be conversant with statutory obligations, and GSK procedures for all regulatory requirements in discipline area; ensure GSK corporate governance is upheld.

Additional information:

Positions available: 2

Reporting line: VP MSAT, Head of Molecule Stewards

People management: up to 10 direct reports

Business travel requirements: 15%. Onsite presence expected in Wavre as most of the team is based in Belgium.

Primary location: Wavre, Belgium

Relocation package: no

Secondary location: Europe, UK, US. The successful candidate will ideally be based in Wavre, Belgium. Applications from candidates located in strategic locations such as Marietta (PA, US), Hamilton (MT, US) will be considered on a case-by-case basis.

Basic Qualifications:

Minimum Bachelor degree level in a scientific discipline with 15+ years of experience in a scientific discipline

Technical knowledge of vaccines - individual to be a company expert, with knowledge of drug product control strategies and unit operations

Leadership: technical acumen, credibility, and communication skills including the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and suppliers

Experience in the Pharmaceutical industry in leading Technical aspects of Product Lifecycle Management

Demonstrated knowledge of Quality by Design and risk management approaches

Knowledge of external regulatory requirements (EMEA, FDA), and internal/external quality and safety requirements.

Experience in technology transfer, with an understanding of the product development process

Knowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle Management

Ability to improve products, processes and trouble-shoot, execution of technical activities including trials and validation activities

Ability to solve problem and to think out of the box (innovative mindset)

Ability to lead technical aspects of investigations

Fluency in English – written and spoken.

Preferred Qualifications:

Ph.D. 10+ years of experience or MSc with 12+ years of experience

Project management and prioritization skills gained within a complex matrix

Fluency in French.

Application closing date: Friday June 14th 2024 EOB

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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.

 
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