Purpose

GSK Vaccines is on a journey to enable ease of use and fast time to market on both systems and development processes and is making fundamental technological and innovative shifts that will enable this journey. To achieve this objective, Manufacturing Science & Technology (MSAT) department has been created to focus on the potential of science to address the unmet needs of patients. GSK commits to those areas where the company thinks we can really change the course of medicine and bring big new ideas to life. This department needs strong and highly experienced technical leaders who understand, master, and control the science and processes used to make the final product with a proven safety, efficacy, and consistency. The Head of Sciences and Technology leads the Manufacturing Science & Technology organisation at GSK Vaccines Singapore site. This role is a key leadership position at the GSK Tuas Site that directly supports product supply, strategic GSK objectives, and other programs at the GSK Primary Cluster. The MSAT organisation is responsible of the following business areas :

• manufacturing support of commercial operations and clinical cGMP Manufacturing,
• equipment, operations and process validations,
• drug substances process improvement of commercial production, and drug substance supply globally,
• product life cycle management of the registered products,
• introduction of new products and new technologies with regulatory launch,
• product strategy and site registration,
• knowledge management.

The Head of Manufacturing Science and technology defines and leads the vision and strategy for the GSK platform, provides product thought leadership in identifying critical process requirements, understanding business goals, defining product end state and roadmaps.

This role is critical in ensuring successful manufacturing readiness, clinical supply and commercial launch/supply through strong leadership and strategic effectiveness. As such, the executive is responsible for defining the strategy and assuring successful technology transfer and ongoing manufacturing for clinical and commercial pipeline. Interacting closely with product development leads, quality, regulatory and other appropriate groups, she/he is responsible for the technical management of existing processes, and continuous support of manufacturing through commercial and life-cycle management. As a key leader in the Technology and Process Engineering department, the Head of Manufacturing Science & Technology is responsible for overseeing validation of pharmaceutical manufacturing processes and equipment to US and global cGMP requirements.

The Head of MSAT reports to the GSK Tuas Site director (direct line) and to the Vice President of Global Process Science (dotted line). She/he is a member of the GSK Tuas Site Leadership Team where she/he has the shared accountability for managing the site manufacturing support and developing & delivering site strategic new products introduction roadmap as well as life cycle of the registered products. This role is also a key member of other technical governance bodies within GSK Global MSAT.

The Head of MSAT leads a group of Managers, Experts and Senior Scientists and Global functions in dotted line to perform and oversee the MSAT activities working in close cross-functional collaboration with members of Quality, Commercial Manufacturing, Process Engineering, Quality Control, Facilities Management, Pharmaceutical Sciences and Regulatory Affairs. She/he provides leadership and direction to the MSAT organisation, a department of 35+ Managers, Scientists, Experts, Training coordinators, and Engineers.

Key Responsibilities Area

Manufacturing Operations :

• Provide technical support to the cGMP manufacturing operation.
• Ensure the robustness of manufacturing processes so that all site products are validated and remain in constant state of validation throughout the product lifecycle.
• Analyse all assigned areas of operations for potential improvement opportunities and makes applicable recommendations for process, system, procedure, and operational changes to improve operations and quality.
• Identification of opportunities and recommendations for change are developed in conjunction with applicable management and staff to obtain their operational expertise.
• Design processes to optimise efficient process flow, reduce process or product variability, improve process capability, and improve employee safety.
• Ensure that process techniques are in alignment with the corporate goals and quality policy.
• Apply appropriate change management methods to promote implementation of technology changes. Facilitate organisational change by helping to prepare personnel to accept and actively participate in new changes, through communication, coaching, and educational workshops.
• Provide technical leadership in the investigations of delivery system failures to determine root cause and implement appropriate corrective and preventive actions.

Product life cycle management :

• Strategize the entire lifecycle of product manufactured at GSK Tuas from inception, through engineering design and manufacture, to service and disposal of manufactured products. Product and process lifecycle management.
• GMP manufacturing of drug substances for development programs and commercial products.
• Conceptualise intermediate to long term data-driven projects to increase process robustness, including continuous monitoring and control of manufacturing processes.
• Ensure site has the capabilities to conduct Product Robustness assessments, risk assessment and remediate gaps.
• Ensure site has the capability to support the product life cycle through material changes, and OPEX/cost reduction/Value Improvement initiatives.
• Develop key and high-quality technical reports required for process validation, stability, and comparability efforts.

Audit preparation and management :

• Represent GSK site in corporate and regulatory inspections and front the inspector’s questions.

Continuous improvement :

• Design an organisation for potential process improvements in conjunction with manufacturing operations, MSAT Manufacturing Support and Global MSAT Process Science teams (Process or equipment improvements, alarms management, OE initiatives, Infrastructure changes, new projects, …).
• Proposes process/product/device improvement opportunities and/or corrective actions to increase yield, maximise capacity, reduce costs and decrease process variability while maintaining regulatory compliance.
• Promote process/product/device improvements, create data packages by justifying and outlining recommendations for changes to or improvements in production processes and collaborate with technical staff to implement process technology initiatives.

New product launches and process transfers :

• Represent the site on the new product committee and the product development process - aiding to set project priorities and responsible for MSAT resource allocation.
• Technology transfer, technology outsourcing, and internal and external manufacturing to deliver a robust supply chain for all drug substances incorporating quality, safety, compliance, cost effectiveness, sustainability and reliability to meet global demands.
• Lead the team that will technology transfer drug substance and drug product manufacturing processes that meet the needs of the company's pipeline.
• Develop and manage the Technology Transfer and Manufacturing teams for clinical and commercial programs, inclusive of the management of external contract development and manufacturing organisations.
• Actively engage with Global MSAT Process Science and site resources to ensure readiness for new product introductions.
• Work with Global MSAT Process Science to commercialise new products.
• Ensure sites have the capabilities to execute the scale up and validation for New Product Introductions.
• Develop and execute plans to transfer products from other sites.

Product strategy & site registration :

• Drug substance regulatory strategy to ensure product quality, facilitate regulatory approvals globally and achieve operational flexibility of supply chain.
• Operational focus, fiscal accountability, and long-term strategy in sync with Global MSAT Process Science pipeline, commercial portfolio, and company strategy.
• Define and lead the vision and strategy for the GSK platform, provide product thought leadership in identifying critical customer requirements, understanding business goals, defining product end state and roadmaps.
• Effectively managing dependencies, priorities and plans across different groups at GSK towards consistent product delivery aligned towards common goals.
• Take a data driven approach in defining success metrics, prioritising requirements, and communicating plans, progress and success.
• Evangelise and create broad awareness around the GSK Platform with technical talks at both internal and external forums and customer events.
• Oversee development operations working on projects ranging from early phase to commercial stage biologics.
• Work closely with Business Development and Manufacturing Strategy teams to identify new business opportunities and new partners.
• Support regulatory filings (INDs, BLAs, MAAs, etc.) and associated product related inspections from Regulatory Agencies (FDA, EMA, etc.).

Organisation management :

• Fostering an inclusive workplace, creating staff development opportunities, encouraging innovation, advocating a quality culture, maintaining safety and achieving high performance.
• Provide leadership and direction to the MSAT organisation, a department of 35+ highly experienced Managers, Scientists, Engineers, Principals and Experts, to accomplish site goals and objectives and to provide process and technical support to enable GSK Tuas site to deliver operational objectives optimally and in compliance with cGMP requirements.
• Promote a productive science-based culture that is motivated and accountable having a customer focus on innovation, quality, and improving the user experience.
• Serve as an active member of the Site Leadership Team responsible for development and setting of site strategy and goals.
• Develop and manage department budgets.
• Ensure the department is positioned well for future growth.
• Ensures clear and definitive linkage between corporate strategy and operational activities.
• Develop an adaptable organisation to handle new technologies from a manufacturing and supply chain perspective.

Training & team development :

• Mentor and develop staff members within the organisation.
• Ensure team development through training, coaching and career mapping; develops personal growth opportunities.
• Identify technical/leadership training needs to develop technical and leadership capabilities in GSK Singapore.
• In partnership with MSAT Learning team, design education/training systems to facilitate the dissemination of knowledge of Product/Process improvement and systems thinking strategies, tools, and practices across the organisation.

Environment, Healh, Safety and Wellness :

• Support, promote and participate in site’s safety and wellness initiatives. Be a role model when appointed as a EHS Committee member, advocate and display safe behaviour and mindset at all time.
• Contribute and support EHS training activities aligned with Site vision and goals.
• Use PPEs correctly while working and follow the safety training and safety instructions and health rules and regulations.
• Contribute to the establishment of an active workplace safety. Be continuously on the lookout for anything that could lead to an accident. Be aware of the behaviour of colleagues too.
• Make daily safety inspections, provide input and feedback. about safety problems and solutions.
• Report all near miss accidents, dangerous occurrences or unsafe situations.
• Participate in enforcement inspections.
• Comply with all applicable safety standards.
• Training and capabilities EHS Standard owner (1.03)

Skills, Knowledge & Experience

• PhD degree in Sciences or Engineering with relevant experience in Vaccines Process Science or Bioprocess Engineering.
• Relevant experience in the bio/pharmaceutical industry in Process Development, R&D, Technical/Clinical Regulatory Affairs or MSAT.
• MBA in Business innovation, Business Development and/or product strategy with substantial industry experience would be an advantage.
• At least 15 years of leadership in pharmaceutical industry in a technical role (R&D, MSAT, Technology Transfer of biologics DS and DP biologic or manufacturing process support) with management experience in R&D.
• At least 4 years in Project Management : major projects with high level of complexity.
• 10+ years of direct experience in a GMP manufacturing environment and 7+ years of senior staff leadership.
• Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages.
• Broad experience in GMP manufacturing across multiple platforms preferred (biologics; immuno therapeutics, synthetics or oral dose).
• Well versed in drug substance manufacturing control strategies
• Strong understanding of Life Cycle Management disciplines, cross functional skills and processes (e.g. Continuous Process Verification, Process evaluation, …).
• Proven track record in data science, DoE, and artificial intelligence.
• Well versed in FDA/EMAE and ICH guidelines relating to registration, quality and compliance concerning biomolecule drug substance.
• Understanding of current industry trends and regulatory expectations associated with QbD and Process Validation.
• Proven track record in business development (Due Diligence, Business Case, Memorandum of Understanding, …).
• Proven ability to apply engineering principles and statistical analysis to resolve manufacturing issues.
• Very strong background in pharmaceutical process development or manufacturing process optimization.
• Experience managing large effective teams both locally and remotely.
• Ability to create functional long-term strategy with substantial influence across multiple sites.
• Experience in the management and leadership of continuous improvement initiatives and matrixed projects that touch multiple functions.
• Identify and champion continuous improvement opportunities to reduce manufacturing risks and close compliance gaps.
• Strong quality mindset and willing to take the ownership in front the challenges.
• Experience establishing and implementing business strategies to address regulatory requirements with a longer-term focus.
• Demonstrated ability to build high performing process technology teams with strong scientific and technical acumen in process science and process engineering.
• Strong proven leadership skills managing matrix teams, influencing outcomes and key project decisions, and strategic problem-solving ability.

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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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