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Project Manager, Project Management CMC Biologics Development

Edison-New Brunswick Metro Area, NJ

Posted: 07/15/2019 Job Type: Scientific Job Number: JN -072019-25227
Summary:
This project management position will support the Biologics CMC development Team of an immuno-oncology product with potential break-through designation, from initial clinical development stages through commercial registration. This is a high priority and a high visibility program with a fast paced and innovative CMC development plan. The Project Manager will be responsible for managing the day-to-day activities of the Biologics CMC team and will be accountable to the Biologics CMC Leader to manage critical path activities and risks, as well as to assist in the development of contingency plans, and to manage overall project planning, cross-functional team meetings, and the development of updates and presentations for management. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members across different functions and at different levels within the organization.

Key competencies:
  • Experience in pharmaceutical development, including broad knowledge of the drug development process. Biologics development experience preferred.
  • Strong project management skills with experience in organizing, prioritizing, planning, and executing multiple medium scale projects from definition through implementation and adoption.
  • Demonstrated ability to earn the trust of team members and management
  • Demonstrated ability to identify opportunities for better alignment, enhanced efficiency, and process improvements.
  • Must be able to interact and communicate effectively at all levels of the organization
  • Must be competent in Project Management tools and methodologies. PMP certification preferred
  • Excellent organizational and time management skills

Requirements:
  • Bachelor s degree with a minimum of 12 years of experience : at least 6-8 years in Pharmaceutical Development and 5 years in Project Management or equivalent. PMP certification desirable.
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