Senior Director, Head of Analytical Science and Technology Leads

Job title:

Senior Director, Head of Analytical Science and Technology Leads

Company

GlaxoSmithKline

Job description

Senior Director, Head of ASTLs (Analytical Science and Technology Leads)The Global Supply Chain 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, with determined strategy executed.MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process, with the primary objective being to ensure manufacturing processes are in control, compliant, performant & cost-efficient and remain state of the art.MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support across the product lifecycle, industrialising new products and new modalities into commercial manufacture and driving any product-related programs within the GSK PCS perimeter.This role is responsible for the leadership and delivery of business-critical projects to support all the analytical aspects related to the late phase of the product lifecycle (PhIII/PPQ/Post Commercial) for key GSK products, across all areas of vaccine and medicine platform technologies- Small Molecules, CHO Platform, Microbial, Nucleic acids- oligo mRNA and MAPS.This position leads an overall team of 20 ASTLs Analytical Science and Technology Leaders with the major responsibilities that include and are not limited to defining the strategy and providing technical and people leadership to implement analytical control strategies, analytical support across the product lifecycle, while implementing new markets and other lifecycle changes for commercial products within the supply chain.Handover of analytical workstream leadership to the group led by this role of ASTLs- Analytical Science and Technology Leaders starts at PPQ and the ASTL becomes the analytical workstream leader post BLA. The position has an essential role in ensuring alignment around specification strategy and overall analytical control strategy across products of the same modality when filing in different regions/geographies. Strong people management and development skills to lead – leaders of leaders and complex matrix projects.In this role you willDirectly leading Leaders of Leaders and SMEs to ensure success of the analytical lifecycle changes and analytical control strategies deliver consistent products across our sites by leading a global group of ASTLs.Demonstrating comprehensive understanding and use of scientific principles and professional practices to solve sophisticated problems in creative and practical ways.Representing and recommending analytical needs at the specification board for post approval products and changes for both medicines and vaccines.Collaborating with leaders of the MSAT analytical hubs to review existing process and analytical development and production data; supporting designs and conducting experiments; interprets results; recommends changes of product prioritization based on the portfolio needs.Providing scientific support and mentorship in the development, scale-up, optimization and operation of methods for the production, purification and testing of new process formulas, technologies, and products.Design, implementation and monitoring of processes for continuous surveillance, to ensure comparability of analytical methods between sites throughout the life cycle of the methods.Providing expertise for product critical quality attribute assessment, control strategy, specification, comparability criteria setting.Leading cross-functional, cross-site teams for product characterization/investigations and other tasks related to product quality and impacts to product release.Authoring, reviewing and/or approving experimental protocols/reports and regulatory submissions.Leading OOS investigations, and other non-conforming results and implementing appropriate corrective and preventative actions.Why you?Basic Qualifications & Skills:We are looking for professionals with these required skills to achieve our goals:BSc, MSc or PhD in a related scientific discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical engineering – preferably Chartered / Professional QualificationPh.D, MSc or BS in a Scientific, Biochemistry, chemical or pharmaceutical engineering, or related field and experience in leading technical teams across multiple geographical areasExperience of Analytical Technologies and Analytical Characterization TechnologiesExperience in development, qualification, and validation of analytical methodsExperience of New Product Introduction and Manufacturing OperationsExperience with IND/BLA/NDA authoringManaging and Developing Directors, Manager and Senior Manager level SMEsPresenting and Leading discussions at the Specification BoardComprehensive knowledge of external regulatory requirements (MHRA, FDA), and internal/external quality and safety requirements.Excellent problem solver and ability to think and work creatively.Demonstrated experience leading technical aspects of root cause analysis investigationsDemonstrated experience in the pharmaceutical industry in leading the technical aspects of Product Lifecycle Management.Demonstrated knowledge of Quality by Design and risk management approachesStrong technical acumen and communication skills with the ability to articulate complex, technical details to stakeholders and enable cross functional collaboration across sites, supply chain, R&D and CMO/CRO.Preferred Qualifications & Skills:Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:PhD level qualification in Biochemistry, Biology, Chemistry, Pharmacy with extensive experienceClosing Date for Applications – 22nd April 2024 (COB)Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.Find out more:.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.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.

Expected salary

Location

Waver, Waals Brabant

Job date

Wed, 10 Apr 2024 01:35:15 GMT

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