Principal Scientist, Facility Operations, Pharmaceutical Sciences Full-time

Maintenance Director For Facilities Control

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.

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.

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.

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.

It is possible the job scope may change at the company's discretion.

It is possible the department and workplace may change at the company's discretion.

Locations: Fujisawa, Japan

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time