Head of msat

Site Name: Singapore - Tuas Posted Date: Nov 20 2024 Purpose The Head of Manufacturing Science & Technology (MSAT) at the GSK Tuas Site is a key leadership role responsible for defining and executing the vision and strategy for the MSAT organization. This role ensures successful manufacturing support for both commercial and clinical operations, oversees process and equipment validations to meet global standards, and drives continuous process improvements for drug substance production and supply. Additionally, the Head of MSAT manages the lifecycle of registered products and spearheads the introduction of new products and technologies, ensuring they comply with regulatory requirements. The Head of MSAT works closely with various departments such as Quality, Regulatory, and Manufacturing to ensure seamless technology transfer and ongoing manufacturing for both clinical and commercial pipelines. This position requires strong leadership to guide a team of Managers, Scientists, Experts, and Engineers, providing direction and support to achieve the organization's goals. The role directly reports to the GSK Tuas Site Director and has a dotted line reporting to the Vice President of MSAT Vaccines. Overall, the Head of MSAT is accountable for managing site manufacturing support, developing and delivering the site's new product introduction roadmap, and overseeing the lifecycle management of registered products. This position is critical for ensuring that GSK's vaccines are manufactured efficiently, meet regulatory standards, and are supplied globally, thereby supporting GSK's strategic objectives and long-term success. Key Responsibilities Area Manufacturing Support: Provide technical support to the c GMP manufacturing operation. Ensure manufacturing processes are robust and all site products remain validated throughout the product lifecycle. Analyze operations for potential improvement opportunities and recommend changes. Develop recommendations for change in conjunction with management and staff to leverage their operational expertise. Design processes to optimize flow, reduce variability, improve capability, and enhance employee safety. Ensure process techniques align with corporate goals and quality policy. Apply change management methods to implement technology changes. Provide technical leadership in investigating delivery system failures and implementing corrective and preventive actions. Product life cycle management: Strategize the entire product lifecycle. Manage GMP manufacturing of drug substances for development and commercial products. Plan data-driven projects to enhance process robustness and continuous monitoring. Ensure the site can conduct Product Robustness and risk assessments, and address gaps. Support the product lifecycle with material changes and cost reduction initiatives. Develop technical reports for process validation, stability, and comparability. Suggest ways to increase yield, capacity, and reduce costs while staying compliant. Identify and propose process improvements with various teams. New product launches and technology transfers: Represent the site on the new product committee, set project priorities, and allocate MSAT resources. Oversee technology transfer, outsourcing, and manufacturing to maintain a robust, compliant, and cost-effective supply chain. Lead the team for technology transfer of drug substances and products. Develop and manage Technology Transfer and Manufacturing teams, including external contractors. Engage with Global MSAT Process Science and site resources for new product readiness. Work with Global MSAT Process Science to commercialize new products. Ensure sites can scale up and validate new products. Plan and execute product transfers from other sites. Product strategy and site registration: Develop regulatory strategies to ensure product quality and global approvals, and improve supply chain flexibility. Align operational focus and long-term strategy with Global MSAT Process Science and company goals. Manage dependencies and priorities across GSK for consistent product delivery. Use data to set success metrics, prioritize needs, and communicate plans and progress. Oversee development projects from early to commercial stages of biologics. Collaborate with Business Development and Manufacturing Strategy to find new opportunities and partners. Support regulatory filings and inspections from agencies like FDA and EMA. Organization and team management/development: Foster an inclusive workplace, staff development, innovation, quality culture, safety, and high performance. Lead the MSAT team to achieve site goals and provide process support in compliance with c GMP. Promote a science-based, motivated, and accountable culture focused on innovation and quality. Contribute to the Site Leadership Team in setting site strategy and goals. Develop and manage department budgets. Position the department for future growth. Link corporate strategy with operational activities. Develop an adaptable organization for new manufacturing and supply chain technologies. 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. Environment, Health, Safety and Wellness: Support and promote site safety and wellness initiatives; be a role model as an EHS Committee member and display safe behavior. Contribute to and support EHS training activities aligned with the site's vision and goals. Use PPE correctly, follow safety training, and adhere to health rules and regulations. Help establish an active workplace safety culture; be vigilant for potential accidents and aware of colleagues behavior. Conduct daily safety inspections and provide feedback on safety issues and solutions. Report all near-miss accidents, dangerous occurrences, or unsafe situations. Participate in enforcement inspections. Comply with all applicable safety standards. Serve as the EHS Standard owner for Training and Capabilities (1.03). Skills, Knowledge & Experience: Ph D degree in Sciences or Engineering with relevant experience in Vaccines Process Science or Bioprocess Engineering. At least 15 years of leadership in bio/pharmaceutical industry in a technical role (R&D, MSAT, process development, Technology Transfer of biologics DS manufacturing process support). 10+ years of direct experience in a GMP manufacturing environment and 7+ years of senior staff leadership. MBA in Business innovation, Business Development and/or product strategy with substantial industry experience would be an advantage. Experience in Project Management in major projects with high complexity would be an advantage. Experience in product/process CMC life cycle management including pre-approval, launch and post-approval stages. 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). Well versed in data science and Do E. Well versed in FDA/EMA and ICH guidelines relating to registration, quality and compliance concerning biomolecule drug substance. Understanding of current industry trends and regulatory expectations associated with Qb D and Process Validation. Proven ability to apply engineering principles and statistical analysis to resolve manufacturing issues. Broad experience in GMP manufacturing across multiple platforms preferred (biologics; immuno therapeutics, recombinant systems). Experience in business development (Due Diligence, Business Case) would be an advantage. Strong background in pharmaceutical process development or manufacturing process optimization. Experience managing 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 of 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. #J-18808-Ljbffr