【今市】MSAT NPI/ Technologist at GSK in Nikko, Tochigi Prefecture, JP

Job Purpose:

The role serves as a subject matter expert responsible for supporting successful product launches, transfers, and lifecycle changes through efficient and effective project execution. Responsible for supporting Site Impact Assessments to assess the impact of proposed changes on the manufacturing site, as well as process design activities including data setup. This role provides in-depth technical expertise on specific technologies, equipment, and systems used in site manufacturing and packaging processes. The role supports efficient and compliant operations through advanced knowledge in system operation, validation, troubleshooting, and process optimization. The role also supports process improvements, root cause investigations, and technology transfers for new processes, equipment and/or technologies.

Key Responsibilities:

• Provide subject matter expertise for site NPI processes to support successful product launches in compliance with applicable standards and regulations.
• Support the development, maintenance, and continuous improvement of area-specific procedures.
• Execute material management activities to create or modify materials within established timelines.
• Support launch and transfer material maintenance activities to meet agreed milestones and delivery dates.
• Contribute to the minimization of write-offs through NPI support and continuous improvement activities.
• Support coordination across functions in the M-ERP Data Maintenance process.
• Provide technical support for discontinuation of factory codes and related system updates.
• Act as a subject matter expert for NPI and technical transfer activities.

*Future scope of job and working location will be determined by company.

Basic Qualification

Skill

• Knowledge of GMP/GDP and good documentation practices, with experience supporting internal/external audits.
• Strong technical expertise: proven ability to provide deep knowledge on manufacturing, packaging, systems, equipment, and process-related topics to support site operations, product launches, and technology transfers.
• Cross-functional delivery and risk/project management: proven ability to work effectively across functions to support execution of complex projects, manage risks, and deliver activities within agreed timelines.
• Results-oriented mindset and continuous improvement: committed to achieving business and quality objectives through strategic thinking, innovation, and a focus on continuous improvement. Drives operational excellence by identifying opportunities for optimization and delivering impactful technical solutions aligned with organizational goals.
• Problem-solving and critical thinking: ability to analyze complex situations, identify practical solutions, and make informed decisions based on data and metrics.
• Good understanding of advanced technology and smart manufacturing, including application of data science and digital tools.

Experience

• At least 5 years of experience in pharmaceutical industries.

Education/certification/Language

• Education: bachelor’s degree or equivalent in Scientific field (e.g. Pharmaceutical Chemistry and Technologies, Chemistry, Biology)
• Fluent spoken and written both Japanese and English.

*Legal right to work in Japan.

Skills CMC Strategy, Data-Driven Decision Making, Data Integrity, Debate Moderation, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Process Optimization, Project Leadership, Risk Awareness, Scientific Writing, Technology Transfer

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels.

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