【大阪】大手製薬会社での外部サプライAPI技術担当者の求人

●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.

●Experience
・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

●Desired
・Project Management Experience.
・Six Sigma Certification