Responsibilities

• Develop a New Product Introduction (NPI) framework and guidance to support the development and launch of Cellares’s Cell Therapy Manufacturing Platform
• Own and drive product and program roadmaps and timelines; define critical paths and own risks and decisions associated with the programs
• Develop and execute communications management plans for the program team, key stakeholders, and business leaders
• Work closely with R&D, Operations, Product Management, Marketing, and Stakeholders to analyze and make appropriate tradeoffs between product features, customer needs/requirements, manufacturability, and cost
• Work closely with NPI counterparts to ensure prototypes, supplier and manufacturing activities are scheduled and tracked appropriately, ensuring adherence to timelines
• Work closely with all internal teams to ensure Design Control and Quality Systems processes are followed per relevant procedures
• Collaborate with the key stakeholders and leadership team to define, manage and own program scope
• Coordinate internally with Engineering, PLM, Finance, and Operations to assure new products COGS are released, report on costs of developmental builds and mass production regularly

Requirements

• B.S. in engineering or life sciences field
• 5+ years of project management experience in the new product development environment
• 2+ years of experience in the new product development environment in medical devices or related fields
• Proven ability to lead, influence and work well at all levels of an organization and in a cross functional team environment
• Comfortable with all phases of the product development lifecycle including concept development, testing, design, implementation, verification, validation and manufacturing transfer
• Thrives in a fast-paced startup environment: comfortable with ambiguity and excited to to both create and implement a vision for NPI at Cellares
• Experience with Smartsheets preferred
• Excellent verbal and written communication, time management, attention to detail, problem solving, acting with a sense of urgency, and enthusiasm
• Should be skilled at working on multiple simultaneous projects
• Knowledge of the cell and gene therapy landscape preferred
• Self-awareness, integrity, authenticity, and a growth mindset