Responsibilities:
- Evaluate and lead technology transfer projects from IND Project Approval (IPA) through Contract Manufacturing Organization (CMO) selection.
- Manage planning and execution of External Manufacturing deliverables for molecule-specific programs (Technical Transfers, Process Validation, new CMO selection, CapEx).
- Serve as single point of contact for communications with CMOs and internal stakeholders (including CMC Program Manager).
- Lead cross-functional teams; prioritize activities and keep teams aligned on a single External Manufacturing project plan.
- Plan and track project activities, including contingency and risk mitigation across the project lifecycle.
- Facilitate regular project-focused meetings with CMOs and working teams (technical transfer, validation, launch).
- Ensure meeting minutes and weekly/monthly reports are completed and distributed.
- Provide flexible project management support across the portfolio as needs evolve.
Qualifications:
- Bachelorβs degree in any physical or biological science.
- Project Manager experience:
- Associate Project Manager: 8 years
- Project Manager: 10 years
- May substitute proven experience for education.
Skills/Experience (This Role Might Be For You If You Have):
- Strong project management, interpersonal, cross-cultural communication, negotiation, and problem-solving skills.
- Ability to provide clear direction in ambiguous situations; proactive issue resolution with tact and composure.
- Resiliency and flexibility; listen well and foster productive teamwork toward a common objective.
- Knowledge of GxP, ISO, ICH, etc.
- Technical expertise contributing to new concepts/techniques/standards.
- Proficiency with MS Project, Excel, PowerPoint, Word.