New Product Introduction Manager

Site Name: Singapore - Tuas Posted Date: Nov 30 2022 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 project/program managers and highly experienced technical experts who understand, master, and control the science and processes used to make the final product with a proven safety, efficacy, and consistency. The role New Product Introduction Manager is responsible for managing a strategic project within GSK Tuas, as part of a key strategic business investment in GSK Vaccines. The scope of the role involves managing a broad spectrum of activities on site, interacting with on-site stakeholders and driving performance in a highly dynamic environment. Specifically, this role will drive new product introduction to GSK Singapore site (product/process/technology strategy and product/process/technology transfer), manage growing portfolio of life science technologies of the site and manage the related non-commercial activities into the site manufacturing plan by defining product/process requirements and to deliver the resulting product to commercial Value Stream with a go-to-market strategy. She/he will also provide strategic direction, advice and training on all aspects of intellectual property, technology commercialization and industry cooperation to external parties. It involves managing co-development activities between Technical R&D (TRD) and Global Industrial Operations (GIO) involving a new manufacturing process for an upcoming vaccine product, technology transfer, driving site (Tuas) readiness in clinical and commercial manufacturing, process scale-up, and process validation. The role is expected to comprise several workstreams or projects; site operational readiness for new product manufacturing, clinical and commercial manufacturing, scale-up and process validation, analytical development & transfer, product lifecycle readiness. This role reports to the Strategic Program Director. Project Management Drive project management on site with all involved stakeholders directly or indirectly. Design, develop and manage processes, procedures and operations to allow the transfer of new product from TRD to industrial commercial operations. Set up governance structure(s) on site involving all stakeholders to track adherence/ performance, manage issues/ escalations, anticipate risks, resolve problems and manage program timelines. Provide leadership to all direct reports and matrixed functions for timely execution of the program. Provides expertise and consultation to project team on technical matters to ensure compliance to applicable corporate, regulatory and external agency regulations. Keeps up to date on regulations/ development of biopharmaceutical process / technology to ensure the project maximizes the use of digitalization, automation and robotics. Stewardship of the growing portfolio of life science technologies transfer of the site. Ensure comprehensive end-to end process, methods and documentation transfer to worldwide Manufacturing sites. Provide senior level technical process & product expertise and front line support from sending to receiving site. Act as a single voice toward GSK Singapore departments to engage, challenge and align the organisation. New Product Introduction Responsible for the deployment of operations of new product introduction within GSK Singapore site. Assure the responsibility of the process transfer from TRD or donor MPUs to worldwide manufacturing departments in line with company strategy. Lead process transfer of new bulk or secondary manufacturing processes to the commercial plants at GSK Singapore plants to agreed standards. Lead the manufacture of the clinical, consistency and stability material (clinical phase 3 and commercial consistency batches) according to GMP standards and the clinical development plan. Implement a networking structure inside GSK Singapore and conduct a transversal management process that guaranties a timely outcome for the new products. Implement structure and run technical process that guaranties compliance according to GSK approved standards and guidelines for new products. Coordinate the schedule of initial / upfront material deliveries with concerned departments to deliver on time the new products introduction at GSK Singapore. Ensure all projects related issues are identified in a timely manner and dealt with actively by the appropriate group level. Regular follow-up of activities to respect major milestones of the different new projects, foreseen in the respective GANTT-charts. Accountable for the phasing of development, engineering and commercial runs in the GMP facility. Co-development with TRD Implements the co-development process together with Technical R&D (Belgium) and MSAT Process Science (Singapore). Preparing the site for commercial production (PPQ batches and beyond) immediately after clinical manufacturing is completed. Ensures that the new process is life-cycle ready immediately after technology transfer. MSAT operations Anticipate, plan and execute the transition from a project mode to routine mode in terms of MSAT operations. Ensures that all functions are ready to support clinical and commercial manufacturing/ testing. Accountable for timely execution of validation masterplan to be in time for source document preparation. Identifies the need for and scope of subsequent local MSAT representatives and supports their onboarding. Support local MSAT management in areas of knowledge management and training for the new processes and testing requirements. Oversee, through the operational readiness representative and quality representative, the successful execution of equipment and process qualification/ validation strategy. Environment, Health, 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 establishement 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. People Responsibilities Define objectives for the team. Provide development for the team. Provide leadership and guidance to the team. Manage the priorities of the team. To ensure appropriate resources and staffing of the team to assume assigned workload and future development. To create a healthy, engaged and inclusive working environment with employees taking accountability, ownership and practising collaborative partnership. To ensure continuous improvement of the team. Actively contribute to standardization and reducing complexity. Skills, Knowledge & Experiences University or advanced degree, in a relevant science or engineering discipline with relevant experience. At least 10 years’ experience in bio/pharmaceutical industry. At least 3 years’ experience in Technology and/or product transfer. Relevant experience in the bio/pharmaceutical industry in Process development, Engineering, MSAT or Manufacturing. Certified project management. Green belt / black belt certification is an advantage. Strong project management skills. Proven experience ideally in a matrix environment. Quantitative & qualitative analytical skills. Proven experience in product and process technical expertise. At least 3 - 4 years leading complex technology transfer projects. A broad technical background in pharma industry with reference to equipment, systems, facilities and regulatory affairs, process validation, commercial launch. Proven technical team management experience. Strong influencing skills. Able to manage highly complex and ambiguous situations. Possesses a continuous improvement mindset. Proven strong experience with complex, multi-workstream project management. Have in-depth knowledge of manufacturing constraints, business processes and inter-relationships of the different business units. Ability to comprehend business needs and translate them into a business/project plan. Planning and organization skills, especially on capacity management. Why GSK Uniting science, talent, and technology 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. *Li-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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. Important notice to Employment businesses/ Agencies GSK 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. 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