Senior Process Engineer

Responsibilities

• Owns the process knowledge of the product(s) assigned throughout the development lifecycle, works collaboratively for comprehensive process mapping, maintains the oversight on process capability, through data trending and statistical analysis of critical variables, ensuring process(es) are robust, in continued state of validation and continuously improving
• Ensures seamless flow of knowledge and information across functions, and with external stakeholders when applicable, with focus on the assigned product(s)
• Works to identify and communicate standards and best practices for process design and manufacturing to ensure consistency across manufacturing of cell therapies
• Work as the Senior MSAT Process Specialist on client projects
• Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations
• Leads technical transfer project team at site and liaises efficiently with involved internal and external functional groups as appropriate
• 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 
• Writing and reviewing relevant SOPs for manufacturing operations and systems, as well as batch records and BOMs
• Support labor and equipment capacity modeling and participate in sales and operations planning process (S&OP) for supply review
• 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
• Support our software team in developing a robust end-user solution for cell therapy manufacturing that integrations with external manufacturing process and data management software including eBR, MES, QMS, ERP, and LIMS
• Provide technical leadership to Manufacturing and other departments associated with GMP operations
• Assess all major deviations including those that impact product quality 
• Ownership of root cause analysis investigations and discussions, including effectively liaising across the appropriate functional teams to drive resolution to major quality events and deviations
• Propose and implement corrective and preventive actions (CAPAs) as necessary and own respective effectiveness checks to ensure recurrence was prevented
• Ownership of process related change controls and change orders, from ideation and change control board review, to implementation and effectiveness check
• Facilitate and/or own the generation of process or operational related Failure Modes and Effects Analysis (FMEA) and resulting mitigations and actions
• Develop training and onboarding content and curriculum for new hires and new methods
• 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, as well as health authority inspectors
• Support for process qualification and validation preparation, execution, monitoring, and reporting
• Work with clients on process mapping of the manufacturing processes

Requirements

• Bachelor’s Degree in a scientific or related field is required
• 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 at all times during the manufacturing 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 and reviewing GMP documentation
• Strong analytical, problem-solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
• Experience with Operational Excellence and/or Lean Manufacturing is a plus
• 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 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