Purpose

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. The primary objective is to ensure manufacturing processes are capable, compliant, in control, continuously improved 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.

Position Overview - The Drug Substance Lead

• is responsible for Global Supply Chain technical leadership of a given small molecule drug substance process, providing leadership across multiple manufacturing sites (both internal and external) as appropriate to ensure the development and implementation of the Product Control Strategy is standardized

• leads technology transfer and then takes ownership of the product control strategy on transfer to Global Supply Chain.

• is responsible for process validation, supports regulatory filing activities, preparation for PAI and technical support through the product lifecycle including knowledge management

Key Responsibilities

• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for drug substance: Technical Risk Assessment, Product Control Strategy, Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards

• Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation of new products from R&D, and subsequent transfers to other sites.

• Responsible for assessing the product quality impact of any change (AL1/2/3) that can impact CQAs/CPPs via review and update of Technical Risk Assessment and Product Control Strategy.

• Leads the technology transfer from R&D and then to other manufacturing sites, internally and externally

• Leads cross functional improvement projects with a clear demonstration of value created

• Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.

• Responds to technical questions during regulatory submission and inspections. Recommends Technical readiness to launch, including technical aspects of Transfer Acceptance Criteria are achieved. 

• Provides leadership and subject matter expertise where required to support the investigation and resolution of product complaints and deviations, in-particular complex investigations.

• Principal point of contact for all aspects of current and previous knowledge on the product and performance, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable for maintaining this knowledge and sharing as appropriate.

• Provides technical leadership and establishes key relationships with the operational teams on manufacturing sites, particularly MSAT, Production, Engineering and Quality and also with R&D.

Skills, Knowledge, and Experience

• Bachelor’s Degree in Science

• Experienced in technology transfer, with an understanding of the small molecule, synthetic, non-biological API 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.

• Track record of improving products, processes and troubleshooting, execution of technical activities including validation activities

• Demonstrated experience in the pharmaceutical industry in leading the Technical aspects of Product Lifecycle Management.

• Demonstrated knowledge of Quality by Design and risk management approaches

• Demonstrated record of achievement and broad integrated knowledge of all aspects of small molecule synthetic, non-biological API production processes, and ability to work effectively in cross-functional teams to deliver results to agreed timelines.

• Broad and integrated knowledge and experience that can impact project and workgroup direction. Working knowledge of regulatory requirements in the industry and drug development.

• Experience in technical support of commercial products, program management, technology transfer to commercial manufacturing sites (internal and to external CMO), process validation and regulatory submission preparation, PAI support for small molecule pharmaceuticals, technical support of product lifecycle activities (i.e., CPV, PPR, Change and Deviation Management), and knowledge management.

• Knowledge of regulatory requirements for small molecule, synthetic, non-biological  API production, including principles of quality by design. 

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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).

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