Summary:
Our client, a biopharmaceutical company located in West Dublin, is seeking a Program Manager (Tech Transfer). The ideal candidate will be responsible for the program management including scope, budget, 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 CMO site. The successful candidate will collaborate closely with technical operations, supply planning, quality, finance, EM&O and other relevant departments. The incumbent will work closely with the internal site or an 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.
Responsibilities:
- Plan and execute multi-discipline tech transfer projects, including project approach and resource needs, ownership through the project delivery phases of planning, process.
- Prepare project charters including business justification for new projects.
- Responsible for the generation of project cost estimates, budgets, forecasting, and long-range plan. In conjunction with finance ensure that there is an appropriate mechanism established for cost tracking/transfer and cross charging.
- Track project deliverables, provide regular project reporting on status to plan and KPIs, schedule and budget reports.
- Manage the decision log and risk register for the project.
- Ensure that the business needs and priorities are clearly understood and that the project execution plan reflects the scope and schedule of these needs and priorities.
- Lead the project team through all project phases from design through to regulatory submission. Engage site functional 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 SG1 agreement to SG6 regulatory approval.
- Provide support to the technical team in creating project management reports/ schedules/plans etc.
- Organise and facilitate project meetings / stage gate meetings in conjunction with the TT leader.
- Ensuring appropriate internal/external communication.
- Ensure the appropriate resources are allocated to the project, Leaders and Steering team.
- 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 relevant team.
- Support the relevant 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 process or tools that are 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 Smart Sheet to allow easy tracking of TT milestones and metrics.
Qualifications & Experience:
- Minimum undergraduate degree in science/business or engineering.
- Demonstrated leadership of technical and / or operational teams or projects within a biopharmaceutical manufacturing organization.
- Experience within new product introduction project work is preferred.
- Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing, aseptic fill finish and finished packaging.
- A working knowledge of regulatory requirements for pharmaceutical industry is required.
- Operational excellence knowledge and application using Lean or six-sigma tools would be advantageous.
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