Project Manager, Manufacturing

Job Summary: The Manufacturing Project Manager will support Cristcot in its growth by supporting the Vice President of Manufacturing and team. This role essentially is the right-hand to the Vice President, Manufacturing and will be responsible for leading and coordinating manufacturing-related projects, processes and programs and budgets for Manufacturing. This role is responsible for but not limited to, planning, executing, and delivering complex projects involving new product introductions (NPIs), technology transfers, equipment validation, and process improvements—while ensuring full compliance with GMP and regulatory standards (FDA, EMA, ISO 13485). Primary Relationships: • Within Cristcot, the Manufacturing Project Manager will collaborate closely with Manufacturing, Finance, Quality, Regulatory, Project Management, IT team, and Launch Team. • Outside Cristcot, the Manufacturing Project manager will engage with external vendors and outsourced functions. Primary Job Responsibilities: The Manufacturing Project Manager leads and coordinates budgets, programs and scheduling and capacity planning from initiation to completion, including new line installations, capacity expansions, and technology transfers. The Activities of the Manufacturing Project Manager: • Collaborate with Manufacturing, Quality Assurance, Supply Chain, and external partners to ensure alignment and timely execution. • Manage tech transfer of formulations and devices from development to manufacturing, including scale-up, pilot runs, and commercial readiness. • Oversee equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation activities in line with cGMP and ISO 13485 requirements. • Prepare and maintain project charters, Gantt charts, timelines, budgets, risk assessments, and progress reports. • Coordinate activities with external manufacturers and suppliers to ensure quality, delivery, and cost targets are met. • Identify and implement Lean, Six Sigma, and process optimization initiatives to improve efficiency and reduce cost and waste. • Support regulatory submissions, inspections, and audits by ensuring documentation and practices are inspection ready. Skills and Qualifications: • Bachelor’s degree in Engineering, Life Sciences, Industrial Engineering, or a related technical field. • 5+ years of project management experience in pharmaceutical and/or medical device manufacturing. • Strong understanding of cGMP, FDA 21 CFR Part 210/211/820, and ISO 13485 regulations. • Experience with equipment validation, process development, and production scale-up. • Excellent organizational, communication, and stakeholder management skills. • Proficiency in project management tools (MS Project, Monday.com, Smartsheet, or similar). • PMP certification or equivalent. • Experience with combination products, sterile manufacturing, or biologics. • Familiarity with MES, ERP, and QMS systems (e.g., SAP, Oracle, Veeva). • Lean Six Sigma Green or Black Belt certification. • Ability to travel 20-25%. Apply tot his job Apply To this Job