Technical Transfer Project Manager
Purpose:
The New Product Introduction (NPI) Manager is responsible for program management, including scope, schedule, and delivery for the Technology Transfer and introduction of a new product, drug substance, drug product, Medical Device, and Finished Packaging either to an internal site or an external Contract Manufacturing Organization (CMO) site.
This role will collaborate closely with Technical Operations, Supply Planning, Quality, Finance, Engineering, Maintenance, and Operations (EM&O), and other relevant departments.
The NPI Manager will work closely with the internal site or external CMO to plan and execute a multi-discipline Tech Transfer project, including project approach and resource needs, schedule, budget, and ownership throughout the project delivery phases.
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Responsibilities:
* Plan and execute multi-discipline Tech Transfer projects, including project approach and resource needs, ownership through the project delivery phases of Planning, Process Preparation, Execution, and Completion.
* Prepare project charters, including business justification for new projects.
* Responsible for the generation of project cost estimates, budgets, forecasting, and long-range planning.
* In conjunction with Finance, ensure that there is an appropriate mechanism established for cost tracking/transfer and cross-charging.
* Track project deliverables and provide regular project reporting on status to plan and Key Performance Indicators (KPIs), schedule, and budget reports.
* Lead the project team through all project phases from design through to regulatory submission.
* Engage site functional Subject Matter Expert (SME) support (Tech Services, Operations, Engineering, and Quality etc.) as required.
* Develop project controls (Project Execution Plan (PEP), schedule, risks) to ensure alignment of project timelines with business needs.
* Communicate progress against plan on a regular basis and develop mitigations for project risks/delays.
* Prepare monthly metrics on project performance, achievements, and statistics.
* Work closely with other site functions to ensure a smooth transition between project and operational phases.
* Responsible for the project management support for the NPI/Technology Transfer of a product across the network using the TT Business Process from initial Site Governance 1 (SG1) agreement to SG6 Regulatory approval.
* Provide support to the Technical team in creating project management reports/schedules/plans etc.
* Organize and facilitate project meetings/Stage Gate meetings in conjunction with the TT leader.
* Ensure appropriate internal/external communication.
* Ensure the appropriate resources are allocated to the project, leaders, and steering teams.
* Work with project controls, Finance, and function leads to manage costs and cash flow according to the approved capital budget and report costs monthly to the Asset Team Ownership (ATO) team.
* Support the ATO team to continuously improve TT practice across the network using a lean and standardized approach that can be replicated and continuously improved for subsequent product transfers.
* Identify current business processes or tools critical to a successful and lean TT process and participate as required in driving necessary improvements in conjunction with the business owner.
* Experience in developing and using Smartsheet to allow easy tracking of TT Milestones and Metrics.
Qualifications:
* Minimum undergraduate degree in science/business or engineering.
* Relevant experience in a pharmaceutical environment at a management level.