Senior Process Engineer

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  Perform manufacturability assessments for new process introductions
• 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. Must comply with safety policies of the company and site
• 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.