Position OverviewThe Sr Engineer or Scientist of Material Science 1 manages the design and development of new single-use consumables in conjunction with our manufacturing teams. This role manages the leachable and extractables program, including organizing testing and creating a data library based on products evaluated. This role also supports manufacturing investigations involving items such as: raw material variability and concerns, consumable issues, particle sources, and provides impact assessments in collaboration with other Process Science subject matter experts (SMEs). Additionally, this role writes investigation reports and leachable and extractable reports. The Sr Engineer or Scientist is the SME for customer and regulatory audits and
articulates the Fujifilm Biotechnologies procedures, practices and rationale.
Job DescriptionWhat You'll Do- Provides oversight and supports the team with the introduction of new raw materials, and associated document requirements
- Ensures regulatory compliance, assesses vendor change notifications, and provides strategic input on raw materials related matters
- Oversees and supports change requests for introduction, modification, and discontinuation of raw materials
- Acts as a scientific liaison between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
- Develops and implements training for manufacturing staff on process improvement initiatives, as needed
- Leads or coordinates troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
- Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
- Supports process sub-teams throughout the phases of technology transfer (TT)
- Serves as SME to support TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
- Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
- Supports generation of sampling plans for process validation reports (PVRs) and investigations
- As technical SME, leads and supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures or policies
- Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
- Leads continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams when applicable, to improve manufacturability, reliability, yield and cost
- Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements
- Other duties, as assigned
Minimum Requirements:- Bachelor's degree in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience; or
- Master's degree in in Engineering, Life Science or Chemical Engineering with 6 years of relevant experience; or
- PhD with 3 years of relevant experience
- Experience working in Good Manufacturing Practices
(GMP) environment
Preferred Requirements:- Prior drug substance or manufacturing experience,including expertise in process validation, transfer and
commercialization, and manufacturing support and troubleshooting - Experience supporting or writing portions of regulatory filings and supporting regulatory audits
- Direct experience with new product launches and validation of
process - Experience managing global or multi-site validation programs
Physical and Work Environment Requirements:- Ability to discern audible cues
