Associate Director or Principal Scientist, Facility Operations, Pharmaceutical Sciences

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Job Description

Please note this job requires business level Japanese in speaking writing and reading.

タケダの紹介

タケダは世界中の人々の健康と輝かしい未来に貢献することを企業の存在意義パーパスとしていますそして目指す未来を共有しながら一人ひとりが自分の可能性を引き出しお互いの個性を認め合う多様性にあふれた先進的な組織作りに取り組んでいます私たちと一緒に世界中の人々のいのちに貢献しさらなる成長と活躍を目指しませんか

タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです従業員は創業時から受け継いできたタケダの価値観であるタケダイズム誠実公正正直不屈を道しるべとしながら患者さんに寄り添いPatient人々と信頼関係を築きTrust社会的評価を向上させReputation持続可能な事業を発展させるBusinessを日々の行動指針としています

Objective / Purpose:

• This position is responsible for GMP manufacturing of biologics drug substances (DS) and sterile drug products (DP) for clinical trials and for their in-process and release testing in compliance with cGMP as the Maintenance Director for Facilities Control.

• Manage the schedule of GMP manufacturing/testing of biologics DS and DP (in the future) and regular maintenance.

• Establish efficient and robust strategy of engineering and maintenance.

• Executes strategic planning and operations in the scheme of facilities control.

• Develops biologics and sterile manufacturing technologies with the improvement of manufacturing efficiency using advanced facility-related technologies including new facility/equipment installation.

• Manage budget for new equipment implementations and maintenance operations.

• Management and training of outsourced contractors.

Accountabilities:

HR Management: Ensuring proper training qualifications and continuous professional development.

Provides strategic direction and oversight to staff to fulfill the following accountabilities.

• Leads to carry out cGMP compliant maintenance on site manufacturing and testing operations to reduce the risk of deviations from armed regulatory requirements and promote continuous improvement.
• Builds and leads efficient and robust maintenance program to ensure stable manufacturing and testing.
• Continues to evaluate and study innovative facilities and equipment technologies and to contribute constantly evolving biologics and sterile manufacturing technologies focusing on cutting edge sciences and technologies.
• Builds good relationships with internal (BPD AD DPDD PS quality EHS etc.) and external stakeholders (Contractors Vendors etc.) to carry out facility maintenance GMP manufacturing testing operations and manufacturing technology development
• Establish and maintain safety working environment.

Education & Competencies :

• Majored or worked in the field of Pharmacy Chemistry Biology Engineering or related field.
• Minimum of 5 years of increasingly responsibility and experience in pharmaceutical industry.
• Minimum of 3 years of experience for GMP manufacturing or maintenance including 1 year experience of construction work management or maintenance work management on-site. Having experiences for biologics or sterile production is preferred.
• In-depth knowledge of any field related to plant engineering such as architecture electricity machinery piping instrument etc.
• In depth knowledge of current relevant international regulatory requirements and guidance for the pharmaceutical industry.
• Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.
• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization.
• Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.
• Ability to analyze a wide variety of information and data to make management decisions. regarding potential risks associated with product quality and regulatory compliance.
• Demonstrated ability to effectively lead and motivate a team of direct reports build on strengths and address areas for improvement.
• In depth knowledge of manufacturing testing facilities and equipment.
• Fluent Japanese communication skill is mandatory and English communication skill is proffered.

Takeda Compensation and Benefits Summary:

• Allowances: Commutation Housing Overtime Work etc.

• Salary Increase: Annually Bonus Payment: Twice a year

• Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30 Production Sites (Osaka/ Yamaguchi) 8:00-16:45 (Narita) 8:30-17:15 Research Site (Kanagawa) 9:00-17:45

• Holidays: Saturdays Sundays National Holidays May Day Year-End Holidays etc. (approx. 123 days in a year)

• Paid Leaves: Annual Paid Leave Special Paid Leave Sick Leave Family Support Leave Maternity Leave Childcare Leave Family Nursing Leave.

• Flexible Work Styles: Flextime Telework

• Benefits: Social Insurance Retirement and Corporate Pension Employee Stock Ownership Program etc.

Important Notice concerning working conditions:

• It is possible the job scope may change at the companys discretion.

• It is possible the department and workplace may change at the companys discretion.

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