Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Technical Project Manager, Vaccines Manufacturing in our Cambridge, 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.
As a Senior Technical Project Manager, Vaccine Manufacturing working on the Technical Development team, you will be empowered to support Vaccine Operations (VO) activities within both the Chemistry, Manufacturing, and Controls (CMC) organization as well as the External Manufacturing (EM) organization which are part of Takeda's Global Vaccines Business Unit (VBU). In this role, you will contribute to Takeda's mission by focusing on leadership and management of complex technical projects, with particular attention on critical initiatives within the dengue portfolio. A typical day will include:
The Technical Development (TD) function supports Vaccine Operations (VO) activities within both the Chemistry, Manufacturing, and Controls (CMC) organization as well as the External Manufacturing (EM) organization which are part of Takeda's Global Vaccines Business Unit (VBU). TD's responsibilities include:
Provide key shared services in support of CMC and EM through the work of the following centers:
- Project Management Center of Excellence
- Validation Center of Excellence
- Analytical Services
VO Management Support for the VBU CMC Head and External Manufacturing Head with governance, budget and business planning activities. Enhance organizational effectiveness across VO. Ensure systems and processes enable teams to do their best work. Promote communication and collaboration across VO.
The Technical Project Manager will be involved in all of the TD responsibilities, but will primarily focus on leadership and management of complex technical projects, with particular attention on critical initiatives within the dengue portfolio.
- Engages and leads global, multi-disciplinary teams working on projects with multiple work streams from initiation to closure to achieve the project's objectives;
- Collaborates with VO functions (Process Development, Analytical Development, Drug Product Development, Manufacturing, Supply Chain, etc.) and with other functions within VBU (Regulatory, Clinical, Commercial, Quality, Finance, Information Technology, etc.) as well as with external partners to create and manage project charters and integrated project plans,
- Manages risk and change, administers budget and measures performance.
- Creates and monitors project charters, budgets, and resource plans
- Builds deep understanding of science and technology involved in critical and complex initiatives and uses that understanding to drive the development of robust cross-functional project plans and to ensure alignment on timeline and deliverables.
- Collects, analyzes, and integrates cross-functional deliverables to support business decisions
- Effectively engages with key stakeholders (internal and external) to ensure timely achievement of project deliverables
- Identifies interdependencies and connections between functions and ensures visibility and alignment
- Executes project logistics, e.g., meeting scheduling, agenda, and minutes and tracking of actions, decisions, % completion on deliverables, and variances to project plans
- Monitors key milestones, decision points, and critical path activities, proactively identifying and escalating issues and solutions to ensure delivery of project objectives in alignment with project plan and charter
- Helps team assess and manage risks
- Drives project management rigor through effective use of best practices Management Support
- Tracks progress against VO goals and Key Performance Indicators
- Responsible for VO financial activities, in partnership with VBU Finance and Business Operations, including budget, mid-range planning, long-range forecast and tracking of contracts, invoices and POs
- Manages CMC documentation to ensure compliance requirements and knowledge management expectations are metEDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- BS or higher in biological sciences with a minimum of 16 years of experience or a MS with a minimum of 14 years of experience or a PhD with a minimum of 12 years of experience.
- Minimum 7 years of project management experience within the biologics pharmaceutical industry in manufacturing, CMC, or R&D
- Demonstrated ability to clearly and concisely communicate/present key information to senior management
- Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions
- Capable of balancing and managing multiple projects, each with varying priorities, timelines, and resources
- Understanding of biomanufacturing processes and technologies, including GMP requirements and systems as well as tech transfer, process improvements and issue resolution
- Experience working with 3rd parties from due diligence through partner management
- Demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions
- Experience establishing and managing global teams across geographic regions
- Project Management Professional (PMP) certification with Project Management Institute (PMI)
- Proven experience in vaccine CMC developmentSkills:
- Ability to assess business needs and apply process and systems-based solutions
- Ability to work across geographic areas with sensitivity to cultural differences
- Ability to establish and articulate processes which impact cross-functionally
- Ability to recognize problems before they occur, to appropriately raise issues to management, to bring an insightful approach to problem solving, and to communicate issues to stakeholders in a mature, professional manner
- Strategic thinking - ability to approach specific issues/problems with understanding of the larger context
- Strong communication skills - written and verbal
- Strong organizational skills
- Negotiation and strong persuasive abilities
- Management skills - ability to handle a variety of diverse tasks simultaneously while achieving deadlines.
- Presentation - ability to present information in a clear and concise manner
- Demonstrate a high degree of self-awareness, self-motivation, initiative, and attention to detail
- Proficiency using Microsoft Word, Excel, PowerPoint, Project, and SharePointLICENSES/CERTIFICATIONS:
- Project Management Professional (PMP) certification with PMI desiredWHAT 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 ProgramsEmpowering Our People to Shine