包装材料研究の求人一覧

新製品のNPIリーダーとして、プロジェクト管理しリード

仕事内容

The role of the NPI Lead is to lead and deliver NPI projects in Japan OPS, according to established standard processes, to the agreed timelines and costs.

Role responsibilities also include project team management, stakeholder management and project communications. It is key for the role holder to understand the customer needs and constrains and to act and lead in an environment with uncertainties and changing assumptions/requests.

This work involves management and oversight of the process establishment to ensure both regulatory and commercial manufacturing readiness in Japan OPS. It also involves preparation, manufacturing and supply of launch stock volumes to meet the forecasted demand from the worldwide markets.

The scope includes both manufacturing and quality control and could cover one up to packaging steps, and high level all steps in the Supply Chain, from raw material procurement to drug substance, drug product, fill, finish, final assembly and packaging. It also includes handover to BAU activities at the site once the new product matures in its lifecycle.

The NPI lead is the Single point of contact from the launch site and the role holder will be expected to represent Japan OPS both internally (GST, GOLT, PDT/CMC teams, JPT, JNDA, CBT and others) and externally when appropriate.

The role holder shows enterprise leadership when integrating in Global teams like the GST and GOLT to deliver benefit and value cross functionally, regionally and globally.

The role holder may also be the launch site representative in Global NPI process networks.

General Project/Programme accountabilities

・Lead cross-functional NPI projects within Japan OPS, involving establishment as well as launch supply to markets.
・Establishing and leading site NPI project teams in accordance with the Project Management Framework (PMF) in order to deliver project objectives efficiently and effectively.
・Facilitate the resolution and handling of a wide range of complex problems with cross-functional team.
・Manage resources and motivate project team members to promote high performance.
・Continuously reviews plan execution against target. Proactively identify potential risks, issues and opportunities, develop alternatives balancing business needs and costs, and ensure key contributors and stakeholders are fully aware of changes and developments. Escalates when decision rights exceed established boundaries.
・Establishes strong working relationships with key internal and external customers and demonstrates personal ownership and accountability for results with a focus on project execution and customer service.
・Support to manage budget costs & benefits associated with their project/programme on behalf of launch site/Operations.
・Manage changes to project scope
・Utilize lean concepts and tools within the overall management of projects. Within NPI project embed lean concepts within solutions and drive continues improvements.
・As a responsible leader, maintain effective employee relations and compliance to cGMP, GDP, other regulatory, and SOX requirements, as well as SHE obligations and standards
・When appropriate, lead and manage deal projects(divestment, tech transfer, other business) in Japan OPS same as NPI projects

応募条件

【必須事項】
・As NPI-lead, it is essential to have following Education and Experience: Bachelor’s degree required in engineering, pharmacy, chemistry or related science, or business related field.
・5 years of experience in and demonstrated knowledge in various aspects of the pharmaceutical industry usually including experience in at least two of the following areas:
Establishment phase: manufacturing management, supply chain management, product development, regulatory/quality assurance, process technology and engineering
Launch phase: manufacturing management, supply chain management, logistics and distribution, finance or commercial.

・As NPI-lead it is essential to demonstrate Project management skills:
・Demonstrated project management skills
・Proven experience in successfully delivering business-critical projects/programs involving cross-functional participants, stakeholders and organizations
・Demonstrated ability to create detailed project plans, meet schedules and timelines, and handle multiple priorities. Ability to plan and execute multiple project tasks and multiple projects concurrently
【歓迎経験】
Knowledge and understanding of all aspects of product life cycle management
・Experience with commercialization and launch of new products
・Knowledge and experience of logistics and planning
・Knowledge of Pharmaceutical Low/Pharmacopeia/Drug approval and licensing procedures in Japan
・Knowledge of and experience with lean concepts and tools
・Technical/expert Knowledge and experience of CMC/manufacturing/product development/quality/regulatory
・Demonstrated understanding of external customer base and supply chain
・Proficient in MS suite of software tools (PowerPoint, Excel, Word, Project)
・Project Management certification

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】大阪

年収・給与

650万円～1000万円　経験により応相談

研究開発部門において、製品開発（主に点眼剤、注射剤）における容器開発の実務担当リーダーとしてご活躍いただきます

仕事内容

担当する製品開発に関して、容器開発研究員として開発初期から臨床、申請・承認にいたるまで一貫して携わっていただき、信頼性・科学性の高いデータを創出することで製品を円滑かつスピーディに医療現場に提供できるようご尽力いただきます。また、日々の業務を通じたメンバーへの指導、育成にも携わっていただくとともに、プロジェクトを強力にリードいただくことを期待しています。

具体的には、以下のとおりです。
・担当する容器の開発・工業化計画立案、試験計画の作成および推進
・新規評価法開発の実行及びデータ取得・当局申請に必要な資料作成
・上市後の安定供給に関わる改良並びに改善
・外部機関（容器会社、CMO、研究機関等）との折衝、交渉並びに管理業務
・容器開発に関する技術及びレギュレーションに関する情報の収集及び管理業務

応募条件

【必須事項】
以下全てを必要要件としています。
・大学／大学院卒業後、製薬、食品、化粧品、医療機器メーカーあるいは容器会社において医療機器または容器開発に従事したご経験（目安：３年程度）
・医薬品開発/医療機器開発/容器開発（主にプラスチック容器）でのプロジェクトリーダー経験
・英語でのコミュニケーション能力（科学的な議論・交渉ができるレベル）


【歓迎経験】
【上記に加え、あれば望ましい経験・スキル】
・局所薬（注射剤、経皮、軟膏、経鼻、経肺など）の処方開発のご経験
・点眼剤あるいは注射剤における容器開発及び工業化のご経験
・医療機器会社または容器会社やCMOへの委受託及び管理のご経験
・英語での高度なコミュニケーション能力（外部受託機関をマネジメントできるレベル）
【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】滋賀

年収・給与

700万円～900万円　

外資大手製薬メーカーの一次容器・包装における選定やデバイス開発

仕事内容

・市場ニーズに基づいた投与デバイスの選定・評価、コンビネーションプロダクトとしてのデータ取得
・材料化学を用いた科学的考察に基づく一次容器・包装の材料選定
・他業界との連携等を通した新規デバイス技術の構築
・デバイス開発に伴うドキュメント対応及び申請資料作成

応募条件

【必須事項】
・修士卒以上（薬学、理学、工学系）
・海外関係会社および他社と英語でのコミュニケーションで業務を推進できる方
・国内・海外のレギュレーション、ガイドラインに関する知識
【歓迎経験】

【免許・資格】

【勤務開始日】
応相談

勤務地

【住所】東京

年収・給与

600万円～1000万円