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GSK

Develops medicines, vaccines, and consumer health

Site MSAT Lead - Manufacturing Science and Technology

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeJapan

About the Job

Requirements

  • At least 7 years of overall pharmaceutical experience.
  • At least 8–12 years of experience in manufacturing processes or the pharmaceutical industry, with a minimum of 5 years of managerial experience.
  • Knowledge of pharmaceutical operations, presentation and communication, computer skills, report writing, and problem solving.
  • Knowledge of EHS and GMP standards and their implementation.
  • Understanding of budgeting and expenditure processes.
  • Detailed knowledge of relevant dosage forms, including unit operations, functionality and criticality of formulation materials and their transformation, such as powder technology, colloid science, isolation, drying and particle-size reduction; plant equipment; and analytical testing.
  • Ability to assess and interpret statistical data, such as process capability, control charts, Design of Experiments, and Measurement System Analysis.
  • Knowledge of the Japanese market regulatory environment.
  • Experience interacting with communities outside Imaichi and with other engineering leads.
  • A bachelor's degree in Pharmacy, Chemical Engineering, or an equivalent degree in an appropriate business or technical area, including scientific, technical, or engineering fields.
  • High business-level Japanese and business-level English.

Responsibilities

  • Provide leadership, technical expertise and support for new product introduction at the site, including product transfers from sister sites, third-party contract manufacturers, or developed branded generics, to ensure timely and complete site manufacturing.
  • Work with the Global MSAT team and engage subject matter experts as needed to resolve technical problems and improve products and processes.
  • Own core site technical business processes, including product lifecycle management, technical risk assessment, product control strategy, continued process verification, process robustness assessment, new product introduction, technical transfer, change control, and risk management.
  • Contribute to strategic planning and business-continuity initiatives that support long-term site development.
  • Support technology transfer and automation efforts and prepare engineering teams to plan and execute effectively.
  • Support translation of product control strategy to the shop floor, including batch instructions and standard work, using GPS principles and matrix leadership across Engineering, VS, Quality and Logistics.
  • Manage product lifecycle and new product introduction processes, including technical risk assessments to identify and manage critical-to-quality process attributes; resolve product-performance issues through DMAIC and CAPA implementation; and monitor technical standards and identify risks.
  • Deliver key process improvement and optimization projects that contribute to site KPIs, including cost of goods, process robustness, cost of poor quality, yield and waste.
  • Keep MSAT-owned processes and ways of working current to provide efficient, effective and compliant technical support to value streams.
  • Be accountable for continued process verification, process transfer, process validation and PPQ, cleaning validation, troubleshooting and root-cause analysis, process mapping, change control, process improvements, statistics, technical standards and process science.
  • Support site quality, EHS and business plans; drive continuous EHS and quality improvements; monitor performance metrics; and ensure alignment with global GSK policies and guidelines.
  • Ensure effective staff selection, training and development to maximize potential and meet business goals, while empowering FLLs and subject matter experts to make informed decisions.
  • Lead by example through leadership behaviors and use performance development plans to drive team growth and performance.

Desired Qualifications

  • A postgraduate degree in a scientific, technical, or engineering field.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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