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Lead, CMC Project Management of Small Molecules

応募後で応募 求人ID R0026332 掲載日 06/15/2021 Location:Hikari, Japan; Jūsō-honmachi, Japan

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Job Description

Please note that this job requires native level Japanese language command not only in speaking, but also in business writing and reading.

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

Takeda is the number one pharmaceutical company in Japan and a global industry leader –we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.

OBJECTIVES/PURPOSE

  • Provide project management expertise to CMC LCM activities for Takeda’s small molecules portfolio
  • Leverage technology platforms and processes to efficiently collect project data and deliver actionable project intelligence through effective use of visualization and reporting
  • Manages cross-functional teams in a highly matrixed environment to ensure successful completion of project goals

ACCOUNTABILITIES

  • Responsible for CMC project management of one or more small molecules APIs as co-lead with the CMC Lead; may also lead CMC subteams for specific LCM projects
  • Responsible for CMC strategy execution to enable effective lifecycle initiatives for supply continuity, risk management, line extensions & discontinuation, launch execution & global expansion/contraction, COGs management, regulatory activities, product / process knowledge, tech transfer, and process validation
  • Use data-driven decision-making processes to enable timely and objective recommendations for continuation, acceleration, reprioritization, redesign of the development plan.
  • Accountable for creating cross-functional plans, budgets, and resource estimates, to drive successful and timely project completions
  • Use agile principles to reduce process complexity and increase organizational capacity

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Ability to analyze unstructured problems, identify root causes and align team objectives to drive business goals
  • Knowledge of Project Management and Process Improvement methodologies (Agile, Lean, DMAIC, Waterfall, SPOT, and/or PMBOK)
  • Understanding of the drug development process and working knowledge of the essential CMC activities
  • Experience capturing and translating business requirements into technical solutions
  • Experience building interactive dashboard using tools such as Power BI, Excel, Power Apps, SharePoint, Microsoft Teams and Flow

Leadership

  • Experience managing projects in a matrix environment
  • Inspires others to share their vision and support them to reach a common goal
  • A firm grasp of organizational development and cross-functional group alignment
  • Aptitude in building a patient-centered best in class organization

Decision-making and Autonomy

  • Accountability for decision making within approved budgets, timeline, and risk profiles and drives decision and approval for changes outside approved scope

Interaction

  • Co-leads CMC teams with functional areas from quality, process experts, product experts, device experts, and regulatory affairs
  • Works across functional area boundaries and sites when needed to bring in additional resources and alignment
  • Works with supervisor for alignment on project management approach for more complex issues

Innovation

  • Capture and disseminate clear, concise project information through global channels
  • Understanding of the drug development process and working knowledge of the essential activities for all key functional area

Complexity

  • Demonstrates initiative, sound judgment and flexibility
  • Possesses effective time management and organizational skills
  • Be able to work under deadlines and on multiple projects simultaneously

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Education / experience

  • BS in engineering, life sciences, or related field with a Minimum 8 years experience, MS with a minimum of 6 years experience, or PhD with minimum 2 years experience in pharmaceutical development and manufacturing
  • Experience operating globally in a matrixed organization highly preferred
  • Experience leading cross-functional project teams

Skills

  • Expert knowledge of Microsoft tools (Excel, SharePoint, Power BI, Power Apps, Power Point, Teams, Project, Visio etc)
  • Knowledge of leadership and project management methodologies (Agile, Lean, DMAIC, Waterfall, and/or PMBOK)


Behaviors

  • Create a project management environment that fosters a patient-focused entrepreneurial mindset

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, 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, Refresh Leave, Maternity Leave, Childcare Leave, Family Nursing Leave, Philanthropy Leave.

Flexible Work Styles: Flextime, Telework

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Locations

Hikari, Japan

Osaka (Juso), Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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