cellares - Director, Global Field Service Engineering
Requirements
• Bachelor’s degree in engineering (mechanical, electrical, biomedical, or related field); advanced degree (MBA, MS, or PhD) preferred • 10+ years of experience in field service, manufacturing engineering, or operations, with at least 5 years in a leadership role • Proven experience in GMP-regulated industries (pharmaceuticals, biotechnology, or medical devices) and familiarity with FDA, ISO, etc. standards • Strong technical knowledge of complex instrumentation systems and their application in GMP manufacturing environments • Demonstrated ability to lead global teams and manage cross-functional projects in a fast-paced, regulated environment • Excellent problem-solving, communication, and interpersonal skills • Experience with process automation, lean manufacturing, and continuous improvement methodologies (e.g., Six Sigma, Kaizen) • Ability to travel globally as needed (up to 40%) • Attendance in the plant site is considered an essential function • Detail-oriented with a commitment to maintaining high-quality standards • Excellent verbal, written, organizational, presentation and interpersonal skills • Self-awareness, integrity, authenticity, and a growth mindset • This is Cellares • Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand. • The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing. • Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Responsibilities
• Define and run the global service strategy and operating model • Own service budget, headcount planning, hiring, and management, and resource allocation • Oversee a global team of field service engineering and factory service engineering ensuring effective installation, maintenance, upgrades, retrofits, repair, and production support of complex instrumentation systems • Oversee a team of instrument manufacturing engineering in Cellares’ South San Francisco headquarters location, to drive improvements in the reliability of Cellares’ GMP instruments globally • Drive continuous improvement in field service, factory service, and instrument manufacturing engineering processes, leveraging data analytics to enhance response times and improve reliability of instruments • Collaborate with R&D and quality assurance teams to support installations and document the installation process • Ensure all activities adhere to GMP regulations and other relevant industry guidelines • Partner with quality, regulatory, engineering, and operations teams to address non-conformances and implement corrective actions • Create, monitor, and report on key performance indicators (KPIs) for field service and manufacturing engineering, ensuring alignment with business objectives • Set OKRs and KPIs for installation and reliability of Cellares instruments • Align service and manufacturing engineering strategies with business goals • Foster a culture of innovation, teamwork, and continuous improvement within the field service and manufacturing engineering teams • Develop and manage budgets for field service and manufacturing engineering operations, optimizing resource allocation • Develop, manage, and implement training plans for global field service, factory service, and instrument manufacturing engineering operations at all sites as Cellares builds out its global footprint • Oversee Change Requests for instrumentation in Cellares’ eQMS • Lead monthly equipment reliability meeting to identify most impactful issues to be prioritized for corrective actions • Improve service processes, response time, and customer satisfaction through standard work and continuous improvement • Drive parts/spares planning, tools, training, and knowledge management
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