Senior Scientist API Oncology & ESSM / 外部サプライAPI技術担当者応募 後で応募 求人ID R0011117 掲載日 08/20/2019 Location:Jūsō-honmachi, Japan
This job requires native level Japanese proficiency in writing, reading and speaking.
GMS外部サプライAPI Oncology and ES SM OpUは、API（原薬）・Intermediate（中間体）・Key Starting Material（重要原料）に関するポートフォリオデザイン、Contract Manufacturing Organization(CMO;製造委託先企業)とSupplierの管理、需給管理、在庫バランスの作成・管理、製造技術支援等の業務を行っているグローバル組織です。部門内のグループは供給計画管理(SupplyPlanning)・製造委託先管理(External Supply Management)・製造技術支援(ManufacturingScience)・プロジェクト管理(Project)に分かれています。
The API Manufacturing Science & Technology (API MST) department with staff located at Boston, Dublin, Zurich and Osaka provides technical solution to support Oncology and ES SM Operating Unit. This is a technical role in a rapidly growing pharmaceutical company where we use an outsourcing model for some of our manufacturing and testing activities. Products supported are primarily complex synthetic molecules. This key role supports new product and technology introduction within the company.
This position will be the primary technical point of contact for the API SM OpU with external Contract Manufacturing Organizations. The primary role will be to provide scientific and technical expertise for all drug substance related activities, ensuring that new and existing drug substance technology and related processes, procedures and specifications are developed and transferred to our contract manufacturing operations (CMOs) in a manner compliant with all regulatory and quality standards and supports cost-effective technical processes suitable for robust commercial production. Roles and responsibilities include, but not limited to:
- New product introduction and New Chemical Entity process validation
- Technology selection and acquisition
- Process design, development, optimization and verification
- Technology transfer
- Continuous improvement
- Routine technical support
- Develop and implement product technology strategies to ensure all API related business needs are met. Work closely with Pharm Sciences for the late stage product development to ensure seamless technology transfer to commercialization
- Optimize manufacturing processes using robust DoE and QbD principles
- Provide on-site technical support at CMOs
- Seek and Implement API improvement plans at CMOs
- Ensure optimal utilization of manufacturing capacity
- Investigate and address API process, quality and compliance issues
- Support inspections by the FDA and other government regulatory agencies
- Write and review all regulatory documents (NDAs, DMFs etc.)
- Manage product risk by understanding potential product risks/vulnerability (technology, safety, compliance etc.) and proactively plan mitigation
- Serve as a lead or member of Product Quality Technical Teams (PQTT). Participate in a cross-functional team to provide technical expertise for all API related matters
- Maintain and communicate project status and general issues to key stakeholders
- Provide technical expertise in matters related to change control, quality and regulatory issues
- Support conformance with regulatory filings initiatives, global agency requirements and safety needs and provide guidance, where possible on global harmonization. This also includes providing technical guidance and knowledge on validation requirements
- Responsible to ensure metrics designed to achieve product and business objectives are effectively managed relative to product cost and life cycle opportunities.
Technical/Functional (Line) Expertise
- Knowledge of the relevant cGMP, ICH and global Regulatory CMC guidance documents applicable to the function. Keep current on all issues that will affect the use of APIs (Regulatory, Stability, QA and HSE).
- In-depth knowledge of Process Engineering Unit Operations and plant equipment.
- In-depth knowledge of QbD, technology transfer, process development, scale up, optimization, DoE and PAT.
- Demonstrated success in technical proficiency, scientific creativity, and independent judgment.
- Able to serve as SME Author on CMC submissions. Support regulatory inspections and audits.
- Able to serve as an effective project team member and inspirational leader. In this capacity should be able to effectively communicate with cross-functional team members as well as stake holders.
- Be Positive, Be Accountable, Be Results Oriented and Be an Excellent Manager of Self and others.
Decision-making and Autonomy
- Understand market needs and key organizational priorities. Translate that understanding into meaningful business cases, as necessary.
- Provide effective API change control management and communicate decisions to all customers internal and external.
- Work independently and make decisions quickly to support an agile organization
- Ability to interact, develop credible relationships and communicate successfully with a broad spectrum of people, including CMO’s, Vendors / Suppliers and Colleagues.
- Strong verbal and written technical communication skills.
- On a routine basis interacts internally in person or remotely with individuals from Product Strategy, Quality, Compliance, External Supply Management, Pharm Sciences, GMSci, Regulatory Affairs and SM OpU.
- Interacts externally in person or remotely with key Suppliers, Contract Manufacturing Organizations, Equipment Manufacturers, Consultant Groups, Regulators, Scientific Experts etc.
- Continuous improvement experience and capable of applying multiple operational excellence methodologies.
- Keep up with the current advances in technology, seek out novel ideas and apply them to provide innovative solutions.
- Ability to effectively and independently develop, implement and manage multiple API projects that are global in nature.
- Works across boundaries to establish common purpose and goals to deliver value to the business.
- Anticipates and removes obstacles so that teams/workgroups can deliver results and succeed.
- A PhD in Organic Chemistry or Chemical Engineering with 4 years or MS with 8 years or BS with 12 years industrial experience.
- Hands-on experience in API process development, optimization and validation.
- Direct experience in technology transfer and in supporting API manufacturing
- Strong knowledge of synthetic organic chemistry and modern analytical methods
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations are preferred.
- Strong technical, interpersonal, communication and leadership skills
- Project Management Experience.
- Six Sigma Certification
昇給・賞与： 昇給 原則年1回 賞与 年2回
勤務時間： 本社（大阪・東京） 9：00～17：30／工場（大阪・山口） 8：00～16：45 ／研究所（神奈川）9：00～17：45
Empowering Our People to Shine
Osaka (Juso), Japan