This is a 6 month contract position.
The CPT Start Up Project Manager will work with other CPT PMs in the development, planning and execution of the start up activities as they relate to Operational, Materials, Tech Transfer, and Stage Gates readiness. This role will be responsible for the start up’s Risk Management process and above site communication. This NPI touches several areas of our brand new facilities such as the Bulk Drug Substance facility, the QC and MST labs, and the GMP Warehouse. The Start Up Project Manager will report directly to Capital Projects Team Lead/Director.
• Develop and lead the operational readiness planning and schedule for the site through PPQ execution.
• Collaborate with global planners and site leadership to set long term execution plan.
• Be involved in the integration of CQV and operational readiness project schedules using scheduling software and will influence the development of schedule scenarios to ensure adherence and integration with other project deliverables.
• Leads the start up Risk Management process, creating a culture of RM within the team with the aim of proactively identify project threats and mitigations.
• Responsible for building the process, toolkits /checklists, and define the schedule required by the team to actively carryout a succesful start up of the facilities.
• Maintains a thorough knowledge of project activities, short and long-term business priorities and objectives through regular communication with other functions.
• Provide updates on a regular basis to functional area directors, associate directors and managers on risks, schedule adherence and performance.
• Lead and develops core planning meetings, with the necessary agenda, input and outputs.
• Measure and report on KPI’s and identify areas of opportunities and prepare specific action plans.
• Collaborate with the CPT team and all the site functional areas and other company support teams.
• B.S. in Science, Engineering, Project Management.
• A minimum of 5-10 years of experience in NPI and start-ups within the Biotech industry.
• Experience working in shutdown environment preferrable.
• Energetic, self-driven individual capable of delivering through others in a sustaining way.
• Knowledge and experience on New product introductions, commissioning, validation.
• Excellent understanding of timelines and schedules and capable of building project schedules.
• Demonstrated ability to manage multiple priorities against ambitious timelines. Strong planning ability.
• Strong problem-solving skills and ability to work cross-functionally as critical member of site team.
• Great communicator and team player.
• Experience working in biologics GMP environments.
• Experience in Drug Substance process and equipment and on the dynamic of a start up.
• Knowledge of schedule software such as Primavera P6 or Microsoft Projects. MS WORD/PowerPoint/Visio/Excel to create documents and presentations.
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