The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

What You’ll Do

• Develops site technical training programs for new processes and procedures
• Collaborates with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support
• Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
• Serves as subject matter expert (SME) to support and lead technology transfer (TT) stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the proposed changes
• As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
• Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams
• Leads one or more projects spanning multiple departments and cross-functional areas
• Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
• Leads process sub-teams throughout the phases of TT
• Develops project plans, timelines, and communication forums to ensure a smooth transfer
• Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
• Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports
• Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
• As technical SME, leads generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads and facilitates technical risk assessments for new manufacturing processes
• Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
• Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management
• Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team
• Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects
• Other duties, as assigned

Basic Requirements

• Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or
• PhD with 5 years of experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)
• Experience with facilitating and training others on RCA and risk assessment
• Project Management experience

Preferred Requirements

•  Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
• Experience authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections
• Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for regulatory findings

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

•  Ability to discern audible cues

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.