Project Management Lead

4 weeks ago

Sydney, New South Wales, Australia KE Select Full time

About the Role

KE Select is seeking a skilled Project Manager to join the team at Viral Vector Manufacturing Facility (VVMF). As a Project Manager, you will play a crucial role in ensuring the success of VVMF's build from startup to fully operational Contract Development and Manufacturing Organisation (CDMO).

Key Responsibilities

  • Project Planning and Management: Develop project plans, timelines, and budgets for key initiatives; monitor project progress and adjust as necessary to meet deliverables.
  • Liaison and Communication: Serve as a liaison between leadership, project teams, and stakeholders, providing clear communication and regular project updates.
  • Risk Management and Opportunity Identification: Identify potential risks and implement mitigation strategies to keep projects on track, and identify opportunities for continuous improvement within the project lifecycle and manufacturing processes.
  • Regulatory Compliance: Ensure that projects adhere to all regulatory requirements (FDA, EMA, ICH, TGA) and quality standards, including Good Manufacturing Practice (GMP).
  • Project Budgeting and Cost Control: Oversee project budgets, monitor expenses, and manage cost control; Report any variances and adjust plans as necessary.
  • Document Management: Maintain accurate, complete, and organised project documentation to support audits, inspections, and regulatory submissions.

Requirements

  • Relevant Qualifications and Experience: Hold a relevant degree in Project Management, Engineering, Pharmaceutical Sciences, or a related field; Demonstrated experience in project management within pharmaceutical, biotech, or a regulated industry.
  • Project Management Skills: Proficient in project management tools (MS Project, Smartsheet) and methodologies (Agile, Waterfall).
  • Leadership and Communication Skills: Strong leadership and communication and interpersonal skills.

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