Sr Leachables and Extractables Material Science Engineer

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

About This Role

The 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 Diosynth Biotechnologies procedures, practices and rationale.

What 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

Knowledge and Skills

• Networks with key contacts outside own area of expertise. Adapts style and uses persuasion in delivering messages that relate to the wider firm business.
• Frequently advises others on complex matters. May be accountable through team for delivery of tactical business targets.
• Organizational impact and influence
• Ability to successfully navigate high stakes, crucial conversations
• Ability to distill complex concepts into meaningful information for all audiences
• Ability to generate mechanistic and theoretical hypotheses
• Advanced project management skills
• Ability to effectively present information to others
• Strategic thinking and self-directed
• Proficient in Project Management and using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
• Excellent communication and teamwork skills
• Exceptional knowledge of material investigation principles and techniques
• Ability to remain current on regulatory and quality requirements for manufacturing

Basic 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

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.