CMC Project Manager - Global Manufacturing Sciences (GMsci), Biologics


  • Lexington, MA
  • Permanent
  • Full-time
  • 1 month ago
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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a CMC Project Manager GMsci Biologics in our Lexington, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

  • Provide project management expertise to CMC LCM activities for Takeda’s biologics 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
  • Responsible for CMC project management of one or more biologic products 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, capability & improvement, 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
  • Strong ability to analyze unstructured problems, identify root causes and align team objectives to drive business goals
  • Strong knowledge of Project Management and Process Improvement methodologies (Agile, Lean, DMAIC, Waterfall, SPOT, and/or PMBOK)
  • Strong understanding of the drug development process and working knowledge of the essential CMC activities
  • Strong experience capturing and translating business requirements into technical solutions
  • Strong experience building interactive dashboard using tools such as Power BI, Tableau, Excel, Power Apps, SharePoint, and Flow
  • Strong experience managing projects in a matrix environment
  • Strong ability to inspire 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
  • Develop diverse talent and elevate organizational performance
  • Full accountability for decision making within approved budgets, timeline, and risk profiles and drives decision and approval for changes outside approved scope
  • Interaction (The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)
  • 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 independently for alignment on project management approach for more complex issues while escalating to line manager for issues cutting across multiple sites or functional areas

Education / experience
  • BS in engineering, life sciences, or related field with a Minimum 8 years experience, MS with a minimum of 5 years experience, or PhD with minimum 3 years experience in pharmaceutical development and manufacturing
  • Experience operating globally in a matrixed organization highly preferred
  • Experience leading cross-functional project teams
  • Expert knowledge of Microsoft tools (Excel, SharePoint, Power BI, Power Apps, Flow, etc)
  • Knowledge of leadership and project management methodologies (Agile, Lean, DMAIC, Waterfall, and/or PMBOK)
  • Create a project management environment that fosters a patient-focused entrepreneurial mindset
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
Empowering Our People to Shine

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Lexington, MA

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Full time