The Project Manager is directly responsible for the support and management of portfolio projects at the MA Bio Ops site. These include but not limited to Strategic Projects and complex Manufacturing Operations projects. The position is responsible for managing cross-functional project teams to on-plan completion of assigned projects, including financial performance. This position will support site and departmental goals through alignment of projects to the site s vision, strategic and operating plan.
- Develop and Maintain Project Management Standards / Templates
- Utilize corporate project management standards, processes and policies
- Assist in developing and maintaining departmental policies and procedures.
- Promotes compliance with all corporate, safety and cGMP standards, procedures and policies.
- Project Planning
- Works with project sponsors to build a project team and assign individual responsibility levels. Identifies project objectives and business drivers
- Collaborate with project portfolio manager, operational excellence and functional leadership teams on project development, chartering and scoping
- Presents charters and project plans to governance bodies
- Provide budgetary, resource and schedule estimates for the requirements of projects
- Plan and Execute projects
- Project Manager
- Sets the project schedule, aligns resources and provides ongoing analysis of financial and schedule performance.
- Develops project execution plans, identifies staffing requirements (internal and external) and develops project budgets
- Drives use of Takeda's Project Management Methodology throughout projects.
- Leads the project team in defining program strategies and goals, and assigns/manages project tasks to ensure the project team meets all commitments.
- Develops and maintains project schedule and budget
- Develops and manages team deliverables/documents required for successful project completion, including URS, scope of work, design documents, change controls, SOPs, commissioning and validation protocols, etc., ensuring appropriate development and approval.
- Responsible for initiation of change control or other quality system requirements associated with projects as necessary
- Manages deployment of resources to efficiently execute tasks, including project meeting management.
- Manages contract, vendor and service suppliers as necessary.
- Develops project reports and makes presentations to governance teams and project sponsors
- Provides clear direction on product/process development requirements and facility/equipment upgrades required to meet expectations of customers and stakeholders.
- Communicates project status updates to all levels of management.
- Anticipates and proactively resolves conflict situations to ensure win-win outcomes.
- Manage all project requirements including engineering design, equipment evaluation and procurement, contractor selection and coordination of all project resources to ensure successful project execution, validation and handover to manufacturing.
- Demonstrates a commitment to continuous improvement of MA Bio Ops PMO business processes
Education and Experience Requirements:
- Bachelor s degree and formal Project Management training required.
- MS, MBA, PE license or professional registration a plus.
- PMI certification and Degree in Engineering or Science preferred.
- Minimum 5 - 7 years of professional experience and 3+ years of project management experience required.
- Experience in FDA regulated environment preferred
Key Skills, Abilities, and Competencies:
- Must be well versed in Project Management tools and possess knowledge of related disciplines.
- Must have knowledge of such principles as GMPs, FDA guidelines and purchasing practices.
- Experience with commissioning and validation concepts, procedures, protocols and requirements to support GMP is required.
- Understanding of biologics manufacturing processes, including upstream and downstream processes and project implementation experience a definite plus
- Must be self-motivated, have good interpersonal skills, and be capable of analyzing and solving problems through innovative thought and experience using project management tools.
- Ability to manage multiple cross-functional teams simultaneously.
- Must demonstrate change management skills.
- Display ability to communicate effectively using a wide variety of techniques and media.
Complexity and Problem Solving:
- The Project Manager will lead and participate in teams to create value through project execution for Takeda.
- Projects may also change business processes which cross multiple functional areas and affect people in all areas of Technical Operations.
- Must be able to assess problem situations and adequately communicate the situation, resolution alternatives, costs and benefits, resource requirements, implications, and recommendations to senior management.
- Management of risk and potential issues impacting the team s credibility, including management of a communication plan for appropriate escalation.
- Influence group decision making for the benefit of the project and the corporation.
- He/she must also know when to step in and make decisions for the greater good of the team without disempowering them.
Internal and External Contacts:
- The incumbent will coordinate with the Head of Business Operations and associate team members, project portfolio manager, project team members, leadership teams, project sponsors, process owners/project leads, functional leaders, other project managers, technicians and supervisors.
- The incumbent may be in contact with Takeda customers, CMOs, vendors and consultants, architects and engineering contractors, construction and/or procurement management contractors, other contract consultants and regulatory agencies.
Other Job Requirements:
- Limited travel (domestic and international) required.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.