Strategic Program Lead

Nama Site: Singapore - Tuas Tanggal Posting: Aug 15 2022
TuasExpansion Immunization is a global health and development success story, saving millions of lives every year. Vaccines reduce risks of getting a disease by working with your body’s natural defences to build protection. Located in Tuas south, we are the only GSK vaccines manufacturing plant based in Asia. The plant is the sole manufacturer of active ingredients for GSK vaccines Synflorix, Infanrix-hexa, Infanrix-IPV/Hib and Hiberix. We are expanding our operations with an exciting new product transfer and are looking for motivated individuals to join us in uniting science, technology and talent to get ahead of disease together. Purpose This role 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 mainly on site, interacting with above/on-site stakeholders and driving performance in a highly dynamic environment. Specifically, this role will manage a transversal strategic program between 3 locations; Singapore, Belgium and United States. 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 validation, capital project spending and construction activities. The strategic program is expected to comprise several workstreams or projects; site operational readiness for new product manufacturing, clinical and commercial manufacturing, process validation, process/analytical development & transfer, product lifecycle readiness. It is the responsibility of this role to ensure that all workstreams are well integrated and move towards the program objective collectively. This role reports to the Site Director and is a member of the site leadership team. Key Responsibilities Program management Drive local program management on site with all involved stakeholders directly or indirectly 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 Participate as the key site representative for all above-site governance meetings & be accountable for all actions and deliverables Provide leadership to all direct reports and matrixed functions for timely execution of the program. Manages the program budget projection and actual spend Co-development Lead New Product Introduction (NPI) by working together with local MSAT and TRD to deliver against program timelines Preparing the site for commercial production (PPQ batches and beyond) immediately after clinical manufacturing is completed Is a key participant to the co-development governance meetings Accountable for process validation strategy and implementation of process validation stage 2. Ensures that the new process is life-cycle ready immediately after technology transfer Operations Lead technology transfer teams responsible for end-to-end transfer of knowledge, process and technology developed by TRD into receiving unit for clinical, process validation, PPQs and commercial manufacturing launch. Manage and direct a diverse team of department representatives in matrix to prepare the facility to start clinical and commercial manufacturing, which includes readiness in the following areas; QC lab, production, raw material availability, supply chain planning 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 In collaboration, with Tech Ops partners (manufacturing, quality, MSAT, QC, supply chain, etc.), ensure timely support for tech transfer, product/process investigations, training and improvement projects. Quality Co-develop the local site quality framework with Quality representative to support acceleration of process development, clinical and commercial manufacturing activities Oversee, through the operational readiness representative and quality representative, the successful execution of equipment and process qualification/ validation strategy. Provide technical support to regulatory filings, health authority questions. Technology transfer Accountable for the phasing of development, engineering and commercial runs in the GMP facility People management Mentor staff and managers. Develop leaders by providing an environment that encourages ongoing personal and professional development. Ensure staff receives appropriate knowledge, skill development and growth opportunities. Work to build a positive culture with key partners and customers in TRD, Operational Team, MSAT, Global Manufacturing, Quality, Supply Environment, Health, Safety and Wellness Support, promote and participate in site’s safety and wellness initiatives. Contribute and support EHS training activities aligned with site vision and goals. Contribute to the establishment of a safe workplace actively by encouraging the development of good safety mindset and behaviours Skills, Knowledge & Experience University or advanced degree, in a relevant science or engineering discipline. At least 15 years’ experience in bio/pharmaceutical industry. At least 6 years’ experience applying strong influencing skills Relevant experience in the Production, MSAT and Quality functions Supply chain and/or Engineering experience are a plus Strong project management skills Strong knowledge of GMP compliance, regulations and manufacturing operations. Experience leading multiple tech transfers to all facility for early stage and late-stage clinical production and PPQ campaign for market application Knowledge of Biologics upstream/downstream process development, working knowledge of analytical method development and method transfer. Knowledge in CMC strategy, ICH guidelines, and regulatory support tasks (IND, BLA, RTQ, and PAI) Experience defining process validation strategy, process validation master plan, process validation protocol and reports Excellent understanding of process engineering/validation and comparability. Strong communication and presentation skills to engage senior stakeholders Possesses strong strategic thinking skills Strong influencing skills Able to manage highly complex and ambiguous situations Possesses a continuous improvement mindset Why GSK Uniting science, talent, and technology to get ahead of disease together At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. *Li-GSK Tujuan kami adalah menjadi salah satu perusahaan perawatan kesehatan yang paling inovatif, berkinerja terbaik, dan tepercaya di dunia. Kami meyakini bahwa kami semua membawa sesuatu yang unik ke GSK, dan dengan memadukan pengetahuan, pengalaman, dan gaya kami, dampaknya akan luar biasa. Bergabunglah dengan petualangan kami di GSK, di mana Anda akan terinspirasi untuk melakukan yang terbaik bagi pasien dan konsumen kita. Tempat di mana Anda menjadi diri sendiri, merasa baik, dan terus berkembang. Pemberitahuan penting kepada Bisnis/Agen ketenagakerjaan GSK tidak menerima rujukan dari bisnis ketenagakerjaan dan/atau agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini. Semua bisnis/agen ketenagakerjaan harus menghubungi departemen pengadaan komersial dan umum/sumber daya manusia GSK untuk memperoleh otorisasi tertulis sebelum merujuk kandidat ke GSK. Mendapatkan otorisasi tertulis sebelumnya merupakan prasyarat sebelum perjanjian apa pun (lisan atau tertulis) antara bisnis/agen ketenagakerjaan dan GSK. Jika otorisasi tertulis tersebut tidak diperoleh, maka tindakan apa pun yang dilakukan oleh bisnis/agen ketenagakerjaan akan dianggap telah dilakukan tanpa persetujuan atau perjanjian kontrak dengan GSK. Dengan demikian GSK tidak bertanggung jawab atas biaya apa pun yang ditimbulkan oleh tindakan tersebut atau biaya apa pun yang ditimbulkan oleh rujukan apa pun oleh bisnis/agen ketenagakerjaan dalam kaitannya dengan lowongan yang diposting di situs ini.