Assoc. Director of CMC Project Management
Edison-New Brunswick Metro Area, NJ
- Associate Director, Project Management CMC Biologics Development
PREREQUISITES Bachelor s degree with a minimum of 12 years of experience 6-8 yrs in Pharma and 5 yrs in Project Management or equivalent. PMP certification preferred
- ummary: 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.
The roles and responsibilities include, but are not limited to, the following:
Manage a high-priority, immune-oncology biologics CMC program with a focus on helping to develop the program strategy and timeline with the team leader, as well as driving the execution of the program.
Effectively manage team meetings, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and the follow up on action items using effective PM tools and systems.
With input from the Leader and the team members, lead the team in the development of an integrated project timeline that is aligned with the Global Project Team objectives.
Manage and drive the various parts of the timeline with the sub-teams and escalate issues to senior leaders in collaboration with the project leader.
Serves as a member of sub-teams to assure that functional deliverables are completed on time, on budget, and according to quality standards.
Proactively identify program risks and work with the team to conduct risk assessments and define appropriate mitigation plans.
Develop critical path analyses to identify potential ways to accelerate timelines and mitigate risks.
Working with the team and team leader, contribute to the development of team presentations for Governance Committee meetings.
Responsible for the preparation of monthly status reports
Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
Coach and mentor team members, as required.
Act as the delegate for the Leader, as needed
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