Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Operations Project Manager 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.
Oversee and manage all project management activities for one or more products or strategic projects and lead multidisciplinary commercialization product teams to ensure proper risk management and contingency plans, fiscal diligence, timely implementation and alignment to long range plans. At times serve as Operations liaison between various domestic and international internal partners (Quality, Regulatory, Sales, Marketing, Finance, Business Development, R&D, Legal) and external partners (Contract manufacturers and packagers, in-license partners). Lead continuous improvement projects associated with the US OpU Oncology and external supply small molecule product portfolio as the change leader for the organization.
- Lead internal team to review CMO performance and identify ways to improve performance, cost reduction, cycle times, etc, throughout the life cycle of the product.
- Coordinate risk management of key Oncology and ES SM products.
- Leading cross-functional product/project teams and improve project management techniques used within the group, across departments, sites, companies and cultures in order to improve project team communication and achieve Takeda s goals.
- Work with Operations team (Planning, Quality, CMO Network Strategy, Engineering, Distribution) and CMO s to assure that appropriate capacities and resources are available to produce inventories required to support successful product launches and supply of on-market products.
- Coordinate the flow of required project/product data to Regulatory personnel for the submission of NDA s, IND s, CBE s, Annual Updates. Review and approve key operational reports, documentation, methodologies, as applicable.
- Review, understand and support product forecasts/launches and demand with CMO s to assure that appropriate capacities and resources are available to produce adequate inventories for successful product launches and ongoing market support.
- A critical role model with mind-set and behavior in the transformation, must exhibit the culture of continuous improvement.
- Leverage best practices across the network; share across regions and with other local Change Agents.
- Responsible for AGILE Program facilitation within the US OpU of Oncology and ES SM function.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor degree required, preferably in health science, engineering, or business
- Minimum of 10 years in pharmaceutical industry related disciplines, Operations experience desirable.
- Minimum of 2 years as a Product or Project Manager or equivalent position
- PMP certification desired
- Experience with Operation Excellence tools and processes
- Good understanding of drug development and NDA process, production processes and technologies, cGMP regulations, and pharmaceutical outsourcing.
- Good understanding of regulatory requirements for most aspects of an NDA, sNDA, annual reports.
- Proficient in application of project management skills and techniques.
- Proficient in presentation tools and techniques
WHAT TAKEDA CAN OFFER YOU:
- 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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.