Join Our Crew

Responsibilities Include

• Develop and maintain project CMC project plans, incorporating activities, internal/external requirements, and key interdependencies to deliver tangible results against program and corporate goals.
• Direct and coordinate multiple projects to ensure on-time and on-budget delivery.
• Identify, define, prioritize, and communicate risks to successful project execution; develop and monitor risk mitigation and contingency plans.
• Provide team meeting management including meeting agenda, action plans, and thorough follow-up.
• Maintain financial accountability for assigned projects ensuring budgets are established, followed, and change controls managed appropriately. Communicate project status to stakeholders and key project participants.
• Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across functions and programs.
• Support the management of external suppliers, including contract manufacturing and development organizations (CDMOs), to ensure timely and high-quality delivery of CMC-related activities.
• Create presentations, dashboards, and reports to communicate project status, key internal metrics, and/or risk mitigations.

Required Qualifications

• Bachelor's degree required with a specialization in science, engineering, or health related field preferred. PMP, or other project management certification preferred but not required.
• 5+ years of CMC experience supporting project operations within a biotechnology or pharmaceutical environment. Cell and/gene therapy experience preferred. Experience support CDMOs required.
• History of motivating others to deliver on important milestones while maintaining a positive, transparent, and collaborative team environment.
• Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word) and MS Project or Smartsheet.
• Capable of creating/updating detailed cross functional project timelines and to guide and align study team members in terms of planning and executing against the timelines.
• Ability to generate high quality meeting minutes and project materials, such as presentations, action trackers, budget, and cross functional resource plans in conjunction with the PTL, team members and functional leads.
• Must display strong analytical and highly proactive problem-solving skills.
• Excellent verbal and written communication, strong organizational and interpersonal skills
• Ability to work both independently and collaboratively with cross-functional teams.
• Ability to work in a dynamic, fast-paced, timeline-based environment.
• Strong team orientation and passion for continuous self-development.
• Experience in industry or in ap industrial setting is preferred.

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