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CMC Project Manager - Global Manufacturing Sciences (GMSci) Biologics

Company: Takeda Pharmaceutical
Location: Pepperell
Posted on: August 4, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role:

  • 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 goalsHow you will contribute:
    • Responsible for CMC project management of one or more biologic products as co-lead with the CMC Lead; may also lead CMC sub-teams 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, and 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 capacityTechnical/Functional (Line) Expertise
      • 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 dashboards using tools such as Power BI, Tableau, Excel, Power Apps, SharePoint, and FlowLeadership
        • 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 performanceDecision-making and Autonomy
          • Full accountability for decision-making within approved budgets, timelines, and risk profiles and drives decision and approval for changes outside the approved scopeInteraction
            • 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 areasInnovation
              • 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 areaComplexity
                • Demonstrate initiative, sound judgment, and flexibility
                • Possess effective time management and organizational skills
                • Be able to work under deadlines and on multiple projects simultaneouslyWhat you bring to Takeda: Basic Qualifications / Requirements:
                  • Master s degree in life sciences, pharmaceutical, or a biotech-related field of study with 5-8 years of industry experience OR
                  • Ph.D. with minimum 3 years experience in pharmaceutical development and manufacturing environment AND
                  • 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) Behaviors:
                    • Create a project management environment that fosters a patient-focused entrepreneurial mindset Preferred Qualifications:
                      • Experience operating globally in a matrixed organization is highly preferred
                      • Certifications such as PMP or Six Sigma a PLUSWhat Takeda can offer you:
                        • Comprehensive Healthcare: Medical, Dental, and Vision
                        • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
                        • 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 and company match of charitable contributions
                        • Family Planning Support
                        • Professional training and development opportunities
                        • Tuition reimbursementImportant ConsiderationsAt Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
                          • Work in a controlled environment requiring special gowning and, wearing protective clothing over the head, face, hands, feet, and body. This may include additional hearing protection for loud areas.
                          • Need to remove all make-up, jewelry, contact lenses, nail polish, and/or artificial fingernails while in the manufacturing environment.
                          • Work in a cold, wet environment.
                          • Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
                          • Work-around chemicals such as alcohol, acids, buffers, and Celite that may require respiratory protection.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Nashua , CMC Project Manager - Global Manufacturing Sciences (GMSci) Biologics, Executive , Pepperell, New Hampshire

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