Salary Range: 90000 to 210000 (Currency: USD) (Pay period: per-year-salary)

Responsibilities

• Manage and work with cross-functional teams to generate CMC strategies and timelines, identification and removal of project roadblocks, and risk mitigation planning
• Partner with Finance to manage program budgets and guide resourcing decisions, including forecasting and approval of invoices
• Support inventory management of custom reagents and materials, including drug substances
• Support preparation and planning of regulatory interactions and filings (e.g., FDA Master Files)
• Track outsourced activities as needed, including management of external vendors from evaluation to closeout, ensuring deliverables are met on time and within budget 
• Continuous improvement of existing systems as well as implementation of new CMC program management best practices and tools
• Provide periodic updates via email, in-person, and/or Zoom with regard to project milestones, schedule, budget, and deliverables
• Investigate and resolve problems, identify root causes, and propose process improvements through clear communication with internal teams
• Capture and document requirements from external and internal stakeholders
• Generate program-related documentation, including but not limited to timelines, communication templates, status dashboards, tracking tools, presentation decks, and final reports
• Work with internal subject matter experts to assist in and respond to any partner or client questions and ad hoc requests during the duration of the program 
• Continually work to streamline processes by creating more efficient methods of gathering, sorting, and accessing data
• Interface and develop strong working relationships with all internal subject matter experts across the organization
• Drive overall customer satisfaction and participation in future partnerships or adoption of Cellares’ Technology Solutions
• Lead cross-functional meetings and facilitate discussions internally and with external partners

Requirements

• Bachelor’s degree or equivalent experience
• 5+ years of relevant professional experience
• Experience with project/program management in a manufacturing environment and interfacing directly with external partners 
• Experience in a regulated biotech or pharmaceutical setting with proven competency and expertise in the CMC/GMP manufacturing space of cell-based therapies is highly desirable
• 1+ year of experience in client services directly interfacing with partners and/or clients
• Ability to understand and communicate scientific and business elements associated with engineered cell therapies
• Excellent verbal and written communication, time management, attention to detail, problem-solving, acting with a sense of urgency and enthusiasm
• High level of customer empathy with active listening skills
• Enjoys problem-solving in a dynamic and rapidly changing environment
• Experience using Google Apps, Project Management Tools (ie SmartSheet or TeamGantt) and CRM applications such as Salesforce