Pharmaceutical Manufacturing Business Project Manager

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Company: Katalyst HealthCares and Life Sciences

Location: Summit, NJ 07901

Description:

Job Description:
  • The Project Manager supports the project teams, cross-functional stakeholders and the PMO for site operations managing Manufacturing Technology, Equipment, and Process, Quality, and Supply Chain related projects.
  • The Project Manager is the primary point of contact for the project and manages all project activities including project kick-off meetings, recurring status meetings, executive sponsor meetings, reporting, and risk tracking.
  • Work to manage resources to attain project deliverables and coordinate project communication for all stakeholders.
  • Serve as a pro-active analytical person and help identify, document, resolve or escalate major risks and issues.
  • Experience working with in a regulated/validated environment is required.
  • It is important that the candidate has experience as a project manager leading complex manufacturing or quality related projects in the Biopharmaceutical industry.
Responsibilities:
  • Leads planning, executing, controlling, and closing the Project to ensure the Project is delivered to scope.
  • Stakeholder identification and management and engagement activities (influence/impact/support).
  • Ensures business objectives and project benefits are identifiable, measurable, and realized.
  • Meet time, cost, and quality objectives for each project.
  • Utilizes internal standards and methodologies to verify scope, schedule, budget, monitor and control.
  • Leads project team to successful delivery.
  • Change management strategy, planning and delivery.
  • Supports execution of change management strategy and plan and work breakdown.
  • Defines change metrics for the project and measure change effectiveness.
  • Collaborates with internal stakeholders to manage expectations and mitigate risk.
  • Facilitates leadership alignment and develops leadership action plans.
  • Develops project communications strategy, approach, and plan.
  • Measures awareness and effectiveness.
Requirements:
  • Engineering degree or equivalent experience.
  • 8 to 10 years of project management experience.
  • Experience/knowledge of Cell Therapy Manufacturing.
  • Pharmaceutical experience.
  • Organization - Ability to manage multiple priorities and resources in a dynamic environment across various departments and organize complex information.
  • Judgment and Decision Making - Considers the relative costs and benefits of potential actions to choose the most appropriate one.
  • Critical Thinking - Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems. Must possess initiative with strong analytical and critical thinking skills.
  • ttitude & Teamwork- Projects confidence tempered with humility. Must be a collaborator willing both to steer the team towards success and to fully support the team when others are steering.
  • Problem Sensitivity -Ability to tell when something is wrong or is likely to go wrong. Recognizes there is a problem and escalates or informs the resources who can address the problem.
  • Making Decisions and Solving Problems - Analyses information and evaluates results to choose the best solution and solve problems.
  • GMP Experience.
  • Description of their Manufacturing, Manufacturing Quality, Supply Chain Quality or Cell Therapy Equipment and processes experience/capability within the pharmaceutical industry.
  • PMP Certification is a Plus.

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