Sr. Scientist , Material Science

Position Overview

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

• Develop site technical training programs for new processes and procedures
• Collaborate with cross-functional teams to support commercial and clinical manufacturing campaigns, including on-floor support
• Lead continuous improvement projects in partnership with Manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost
• Serve 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, provide supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required
• Identify opportunities to improve systems and practices and provide direction to local and global cross-functional teams
• Lead one or more projects spanning multiple departments and cross-functional areas
• Provide engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes
• Lead process sub-teams throughout the phases of TT
• Develop project plans, timelines, and communication forums to ensure a smooth transfer
• Lead troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations
• Lead 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
• Write, review, and approve master batch records (MBRs) and standard operating procedures (SOPs)
• As technical SME, lead generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies
• Generate and execute process training and consult on topics related to manufacturing and process
• Lead and facilitate technical risk assessments for new manufacturing processes
• Provide interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations
• Lead and coordinate analysis of manufacturing process performance and reporting to manufacturing management
• Support 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
• Deliver 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

Minimum Requirements:

• Bachelor’s degree 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

Physical and Work Environment Requirements:

• Ability to discern audible cues

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().