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Project Manager (3414)


Summary:
This Project Manager position will provide project and technical leadership for the development and commercialization of multiple Pharmaceutical solution products. They will represent Manufacturing on solution product development cross functional teams and ensure communication to stakeholders both at the Manufacturing facility and within the PMO. They will be responsible for the utilization of Project Management tools to coordinate all activities required at the Manufacturing Facility as defined within the cross functional teams.
They will insure budget alignment both within the manufacturing facility and the PMO. They will lead the formation of the core team at the Manufacturing facility to insure project plan alignment and successfully deliver project activities such as: Process Evaluations, Stability Manufacture, Cleaning Validations, Filter Validations, Time to Freeze Validations, Micro method validations, Analytical method transfers, Laboratory equipment qualification, Regulatory submission, Receiving and Inspection, development of pFMEA's and Control Plans and the issuance of manufacturing and laboratory documentation.
Responsibilities:
o Accountable for core team performance, project schedule and execution, budget commitments and spend o Leads team in defining project strategies, developing goals, and ensures project scope is defined and controlled o Continuously interacts with all functions and levels of management ensuring effective ongoing communications across teams and stakeholders o Ensures identification and communication of project risks within the core teams and drives proactive management of risk response strategies o Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes o Leads team to identify and implement continuous improvement
Qualifications:
o Business acumen o Competent application of Vital Behaviors and Leadership Essentials o Understanding of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Process requirements o Demonstrated competencies in all aspects of project management o Ability to develop and interact with others o PMI or IPMA or equivalent certification desired o Microsoft Office proficiency o Therapeutics Product Development Process o Change Control Process
Education/
Experience:
At the discretion of the hiring manager, the minimum is a Bachelor's or equivalent plus 5 years project management experience in Pharmaceutical Solutions development and commercialization in a manufacturing environment.

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