Job Description Summary: The Contract - CMC Development Project Coordinator will assist in driving the development of client's Gene Therapy portfolio. This position is in the CMC development team within Technical Operations and will be responsible for providing project management to support CMC activities. The position requires in-depth interactions with CMC-Leads, scientists, engineers and stakeholders from various functions and external vendors.

The Work:

• Joint responsibility with CMC and Drug Substance (DS) leads to establish a master plan for process development, technical transfer, clinical manufacturing, drug substance validation and launch.
• Define and manage critical paths, proactively identify and escalate risks.
• Joint responsibility with CMC leads in preparation of detailed project plans, timelines, monthly dashboards and progress reports.
• Monitoring of project plans and budgets, in coordination with CMC and DS leads.
• Facilitate internal meetings in coordination with CMC and DS leads.
• Effectively engage with key stakeholders to ensure the timely implementation of project objectives.
• General support for project activities, department operational excellence monitoring and help allocate and manage resources

Desired Education and Skills:

• This role requires experience with project management in drug development.
• Bachelor’s degree and 8+ years of relevant experience is required.
• Must have exceptional working knowledge of CMC operations relating to research and development and clinical trial manufacturing.
• Demonstrated excellence in project management and effectively managing multiple projects/priorities. Ensures budget schedules and deliverables are met.
• Experience with tech transfer and new product launch is preferred.
• Ability to work well in a cross-functional, fast-paced team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions. Proven experience coordinating among stakeholders with both business and technical priorities.
• Effective communication, presentation skills and adept at multi-tasking.
• Recognized by former peers, colleagues and managers for attributes congruent with client Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
• Proficiency in MS office applications and other project management applications

Onsite Tuesday/Wednesday/Thursday; Starting in Burlington, MA and will transition to Bedford, MA starting June 2025.

Please note: We are not accepting submissions from third-party recruiters or staffing agencies at this time.