Department Mission 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, youHave 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: 2Reporting line: VP MSAT, Head of Molecule StewardsPeople management: up to 10 direct reportsBusiness travel requirements: 15%. Onsite presence expected in Wavre as most of the team is based in Belgium.Primary location: Wavre, BelgiumRelocation package: noSecondary 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.Why You?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Minimum Bachelor degree level in a scientific discipline with 15+ years of experience in a scientific disciplineTechnical knowledge of vaccines - individual to be a company expert, with knowledge of drug product control strategies and unit operationsLeadership: 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 suppliersExperience in the Pharmaceutical industry in leading Technical aspects of Product Lifecycle ManagementDemonstrated knowledge of Quality by Design and risk management approachesKnowledge of external regulatory requirements (EMEA, FDA), and internal/external quality and safety requirements.Experience in technology transfer, with an understanding of the product development processKnowledge of current and emerging Regulatory Strategies (Quality by Design, GMP for 21st century, ICH Q7, Q8, Q9, Q10) and Product Lifecycle ManagementAbility to improve products, processes and trouble-shoot, execution of technical activities including trials and validation activitiesAbility to solve problem and to think out of the box (innovative mindset)Ability to lead technical aspects of investigationsFluency in English – written and spoken.Preferred Qualifications:If you have the following characteristics, it would be a plus:Ph.D. 10+ years of experience or MSc with 12+ years of experienceProject management and prioritization skills gained within a complex matrixFluency in French.Application closing date: Sunday, April 21st 2024#LI-GSKIf 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 Us?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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.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.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.
