Senior Process Engineer

Position Summary

We are seeking an innovative and highly motivated Senior Process Engineer on our MSAT team who will contribute significantly to the development of our advanced cell therapy manufacturing platform. This position is responsible for supporting the activities involved in development, process transfers, compliance, and scalability for Cellares’ manufacturing operations.

Responsibilities

• Work to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
• Work as the MSAT representative on client projects
• Lead activities to transfer processes to manufacturing from internal Cellares process development at other sites or directly from customers
• Lead Master Validation Plan creation in order to support PPQ campaigns
• Lead and drive technology adoption program initiatives, including ROI analyses with internal and external stakeholders
• Support development of manufacturing operations including GMP system implementation and tasks related to GMP readiness
• Support process development and process comparability activities on Cellares technology as required
• Support development and review of relevant SOPs for manufacturing operations and systems. Author and review global program policies
• Define and provide user requirements for process equipment associated with multiple facilities for the manufacture of cell therapies
• Work with our software team on integration solutions for the manufacturing process and data management, including eBR, MES, QMS, and LIMS
• Work with our software team to provide feedback on internal software solutions
• Provide technical support to Manufacturing and other departments associated with GMP operations
• Support or author product quality impact assessment for major deviations. Provide input when troubleshooting processes on the manufacturing floor and during post-operational investigations
• Maintain and report process run summaries, and continued process verification reports
• Prepare and present data associated with manufacturing processes to internal and external partners
• Support for process qualification and validation preparation, execution, and reporting
• Work with clients on process mapping of the manufacturing processes
• Other duties as assigned

Requirements

• Bachelor’s Degree in a scientific or related field is required
• A minimum of 5+ years of experience within the biotech/biopharma industry in cGMP Operations, preferably within cell and gene therapy
• Experience in the Pharma/Biotech industry in technology transfer
• Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries
• Adherence to cGMPs is required all times during the manufacture of Cell Therapy products. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions
• Relevant experience bringing biotechnology equipment and processes from design through GMP operational readiness is a plus
• Must have experience writing, reviewing and approving GMP documentation
• Self-motivated and passionate about advancing the field of cell therapy
• Self-awareness, integrity, authenticity, and a growth mindset
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level
• Excellent planning, organization, technical writing, and time-management skills including the ability to support, problem-solve, and prioritize multiple projects and deadlines

Pay

$90,000 - $210,000 a year

About the Role

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.