Site MSAT(Manufacturing Science and Technology) Lead Imaichi

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

今市工場適切な品質の医薬品を確実にお届けする GSK グラクソスミスクライン

栃木 GSK グラクソスミスクライン

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

選考プロセス書類選考 面接3-4回 (WEB 対面)

就業場所

グラクソスミスクライン株式会社

今市工場住所321-1274 栃木県日光市土沢1506

JR日光線下野大沢駅下車タクシーで約10分

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

完全週休2日制土日祝日年末年始5月1日四季休暇５日出産休暇通院休暇子の看護休暇学校行事休暇介護休暇公傷休暇ほか

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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