Job Description

Job Purpose

Provide leadership, technical expertise and support for the new products introduction at site through product trasfers from sister sites, 3rd party contract manufacturer or developed branded generics to ensure that new products are manufactured site on time and in full. Work closely with Global MSAT team, engaging appropriate Subject Matter Experts (SME) support as required to rapidly resolve technical problems and improve products and processes.

Key Responsibilities

1. Strategic Planning

• Own core technical business processes for site: Product Lifecycle Management (Technical Risk Assessment, Product Control Strategy, Continued Process Verification, Process Robustness Assessment), New Product Introduction and Technical Transfer to/from other sites/ 3rd party contract manufacturer / developed branded generics, Change Control and Risk Management.
• Contribute to strategic planning, based on those above and business continuity initiatives to support long-term site development.
• Support technology transfer and automation efforts while preparing engineering teams for effective planning and execution.

2. Operational Business

• Support product control strategy translation to shop floor (batch instruction, standard work etc), utilizing the principles of GPS with matrix leadership across Engineering, VS, Quality and Logistics.
• Ensure product life cycle management, including NPI processes - technical risk assessment activities to ensure critical to quality attributes in the processes are identified and managed, product performance – solving technical issues through DMAIC and CAPA implementation, and risk management – monitoring technical standards and identifying risks.
• Delivery key process improvement/optimization projects that contribute to site KPIs: cost of goods, process robustness, cost of poor quality, yield and waste to continue to improve site competitiveness.

3. Compliance and Procedural Implementations

• Ensure MSAT owned processes and ways of working are up to dated to provide efficient, effective and compliant technical support to values streams.
• Accountable and responsible for continues process verification, process transfer, process validation / PPQ, cleaning validation, trouble shooting / RCA, 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.

4. People Management & Development

• Ensure effective staff selection, training, and development to maximize potential and meet business goals, while empowering FLL and SMEs to make informed decisions.
• Lead by example through strong leadership behaviors and utilize performance development plans to drive team growth and performance.

Basic Qualification

Skill

• Pharmaceutical Operation Knowledge / Presentation & Communication / Computer Skills / Report Writing / Problem Solving
• Overall Pharmaceutical Experience of 7+ years
• Management experience of workforce with direct and functional affiliations to execute operations
• Well acquainted with EHS and GMP Standards and their implementation
• Understanding of budgeting and expenditure processes
• Detailed knowledge of relevant dosage form including unit operation understanding, functionality, and criticality of formulation materials and their transofmration (e.g. powder technology, colloid science, isolation, drying and particle size reduction), plant equipment and analytical testing.
• Able to assess/interpret statistical data; e.g. process capability, control charts, DoE, MSA.
• Knowldege of Japan market regulatory environment.
• Interaction with other community (outside of Imaichi) and also with other engineering leads

Experience

• 8-12 years minimum experience in manufacturing processes / pharmaceutical industry, with a minimum 5 years managerial experience

Education/certification/Language

• Bachelors degree in Pharmacy or Chemical Engineering or equivalent in an appropriate business / technical area（ Scientific, Technical, Engineering ）
• Japanese: High Business-level; English skill: Business-level

Preferred Qualification

Education/certification/Language

• Post graduate degree （ Scientific, Technical, Engineering ）

*Future scope of job and working location will be determined

関連リンク：

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ご応募について：

・海外との面接がありますので、英文CVをWorkdayにご提出ください

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東武日光線下今市駅下車タクシーで約15分

日光宇都宮自動車道大沢インターから約10分

休日：

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雇用形態：正社員

賞与：あり（年１回）

昇給：あり（年１回）

通勤手当：対象

各種保険：対象

年次有給休暇 ：対象（初年度1-15日：入社月により変動、２年目以降15日）

試用期間：３か月

リモートワーク：可（週1日）

社宅制度：あり（適用対象は規定による）

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