Senior Director, Head of Analytical Science and
Il y a 2 mois
**Site Name**: Belgium-Wavre, Rockville Vaccines, Upper Merion, Ware
**Posted Date**: Apr 8 2024
**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 will**
- Directly 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 Qualification
- Ph.D, MSc or BS in a Scientific, Biochemistry, chemical or pharmaceutical engineering, or related field and experience in leading technical teams across multiple geographical areas
- Experience of Analytical Technologies and Analytical Characterization Technologies
- Experience in development, qualification, and validation of analytical methods
- Experience of New Product Introduction and Manufacturing Operations
- Experience with IND/BLA/NDA authoring
- Managing and Develo
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