Head of Manufacturing Science, Japan Plasma New Facility Program

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Job Description

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company. We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transform the lives of patients. We’re looking for like-minded professionals to join us.

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.

Summary

The Head of Manufacturing Sciences is responsible for the direction and leadership of the organization through defining and prioritizing tech transfer projects and process validation strategies within Japan Plasma New Facility Program. This role is in close contact with the pharma science/regulatory/quality control organizations and process experts across the plasma global network. Additionally, this position will develop organizational strategies that will drive the successful tech transfer of plasma processes and products to the new plasma facility in Japan.

Essential Duties and Responsibilities

• Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.

• Direct team members to effectively transfer technology from design development to implementation. Evaluate the suitability of new technologies for implementation and transition to the manufacturing floor. Responsible for successful product technical transfer to the new plasma facility.

• Establish reliable yield status and accurate yield forecasts for all transferred products together with strategies to meet the yield targets. Develop and direct strategies to drive yield improvement projects, to reduce lead times, to secure the process and to reduce deviation.

• Assure process robustness and supply reliability by controlling the manufacturing process life cycle from process / product development and authority submission to commercial production.

• Develop strategic plans that incorporate regional and global business practices and customer needs.

• Define and communicate strategic imperatives to project success (Ex - timing of market entry, innovative technology, and costs).

• Develop effective tech transfer project milestones, schedules and manage budgets, including capital. Employ state-of-the-art project management tools to manage to those project schedules and budgets against milestones; review and apply best-demonstrated practices, team processes, and improve operational efficiency. Identify and resolve issues that may jeopardize project schedules or improve project time.

• Understand and effectively communicate to team members about the market niche, competitive forces influencing the project, and how the project fits into the function's strategic focus/plan. Ensure that team objectives align with key tech transfer projects for the new facility. Accountable for successfully meeting agreed upon milestones for the new facility program.

• Proactively prioritize and balance utilization of resources allocated to project; identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/project, present internal vs. external analysis.

• Select, develop, and retain staff. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Successfully coach, mentor and motivate others for outstanding performance.

• Generate innovative solutions to complex problems using multiple disciplines and technical principles. Create innovative products/processes/methods through novel combinations of expertise within the organization.

May perform other duties as assigned.

Qualifications

• Must be well versed in scientific disciplines.

• Proficient in knowledge and application of various principles such as GMPs, FDA, EMA, PMDA, Lean, Six Sigma and DMAIC methods.

• Be self-motivated, strong interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience, as well as project management tools.

• Ability to manage multiple cross-functional teams simultaneously.

• Ability to design and implement projects/studies outside area of expertise.

• Must demonstrate strategic leadership and proficient supervisory capabilities.

• Very successful track record of change management projects and processes.

• High level of customer orientation and organizational skills.

• Flexible in mind / out of the box thinker.

• Enthusiastic, decisive, motivating, and influential personality

• Excellent communication skills, verbal, and written communication skills

• Record of success in process development, tech transfer, project management and regulatory submissions

Education and/or experience

• Bachelor’s degree in science related field required; Master or PhD degree in technical / scientific education, preferably biochemistry, biotechnology or pharma is preferred.

• At least 10 years professional experience in a similar role in the field of Technical Operations, Process Management, Manufacturing within the pharmaceutical industry, preferably biotechnology

• Excellent verbal, written and interpersonal communication skills in English and Japanese.

• Ability to build relationships, influence and drive organizational engagement in highly matrixed, cross-functional and geographically dispersed environment.

• Experienced in GMP inspections.

Working Environment

• Normal office environment usually

• Must be able to work in controlled environments requiring special gowning.

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 company’s discretion.

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

• Fixed-term contracts may be renewed after the end of the contract period based on the workload and employee performance. The total contract duration shall not exceed 5 years.

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