外部サプライAPI技術担当者/Principal Scientist or Senior Scientist API Oncology ESSM / 武田薬品工業株式会社
|職種||外部サプライAPI技術担当者/Principal Scientist or Senior Scientist API Oncology ESSM|
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
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.
|求める経験||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 delive
|年収||800万円 - 1200万円|