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Program Manager (Biopharma)

Job description

This is a temporary multi-year role required to commercialise new equipment being introduced to the client's site. The Program Manager will be accountable for making the plant extension ready to introduce existing commercial product portfolios onto a new commercial line.

The Program Manager will partner with the Capital Projects Manager to pull the capital project into plant ownership.

The Program Manager will provide leadership to functional workstreams tasked with making the new plant and equipment operational. This includes all functional interfaces such as Capital Projects, Production, F&E, Supply Chain, Process Development and Regulatory workstreams.

The Program Manager will report to the F&E Site Lead and report out to the Site Leadership and Corporate Engineering Teams through governance processes and as dictated by the needs of the assignment.

Requirements: 

  • Delivers an operationally ready plant and operationally ready processes.
  • Develops detailed execution plans with workstream leads and guarantees delivery of these execution plans.
  • Delivers seamless transition from Project Team to Operational Team.
  • Provides direction, sets high expectations and measures workstream performance in making the site operationally ready for product transfer to the new line.
  • Provides clear definition of workstream scope, roles and responsibilities and resolves disputed areas.
  • Alerts senior management of significant program quality, compliance, and safety risks.
  • Resolves workstream issues arising throughout the project, manages risk logs, and escalates when appropriate to keep objectives and deliverables on track.
  • Provides input, innovative solutions and options to the workstreams to maintain solution integrity and meet project timelines.
  • Ensures that the workstream team deliverables are aligned with existing high standards of Safety and Quality Compliance, Qualification, Validation and Operating Standards as well as established and evolving regulatory requirements.
  • Communicates effectively with Project Team, Workstream Teams, Site Leadership Team and Corporate Engineering.
  • Ensures adequate workstream team resources are provided to deliver as outlined.
  • Thinks LEAN and embeds LEAN concepts into program delivery.
  • Manages all interfaces with site engineering functions.
  • Manages all interfaces with corporate engineering functions.
  • Routinely reports progress against deliverables and key performance metrics.

Qualifications:

  • Senior Functional Manager or Director Level, Program Manager equivalent with 7-10 years’ experience in leading cross functional project or program teams.
  • Experience of technical challenges of working in a sterile Fill Finish biopharmaceutical environment.

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