About This Role

The Engineer / Scientist 3 of Process Analytics provides support and leads technology transfer and technical oversight activities during manufacturing operations. This relates to process analytics data management systems, trending processes, and advanced analytic tools. This role leads junior team members through activities such as technology transfer, process impact assessments, and provides guidance as needed.

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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 solutions to 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.

What You’ll Do

• Coordinates the execution of site readiness, technical transfer (TT), and ongoing manufacturing support activities by ensuring configuration and maintenance of compliant trending systems
• Partners across functions to ensure alignment and delivers projects on time and in full completeness
• Develops project plans that integrate with other scheduling functions within the organization and in alignment with program scope
• Escalates risks and tracks milestone progress while ensuring cross functional communication to key stakeholders
• Builds and maintains routine statistical process control methods and multivariate models for process trending and monitoring
• Performs ad hoc statistical analysis, as required
• Closes deviations and provides a thorough explanation of findings to internal and external teams
• Documents process performance and product health through process trending, monitoring, and supporting annual product reviews, manufacturing campaigns summary reports, model validation reports, impact assessments etc.
• Conducts technical risk assessments for new manufacturing processes from a process analytics (PA) perspective
• Trains relevant stakeholders on process analytic tools and respective analytical approaches (e.g., multivariate models, Process Analytical Technologies (PAT), and Statistical Process Control (SPC) methods)
• Serves as on-call for PA issues and concerns
• Supports role in Good Manufacturing Practices (GMP) environment
• Leads troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Generates and reviews master batch records (MBRs) and sample plans, as needed
• Participates in site data stewardship and data activities to ensure data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholders
• Coordinates informatics, data systems improvement initiatives, and evaluates new analytical technologies (e.g., PAT, data science tools) and solutions to improve scalability, manufacturability, reliability, yield and cost
• Coordinates the curation of critical knowledge related to PA systems and multivariate modeling
• Identifies, and supports the prioritization and planning of improvement opportunities
• Contributes to the development of business cases and improvement plans
• Writes and reviews standard operating procedures (SOPs), work instructions, and white papers, and other relevant documentation
• Builds awareness of industry trends and customer requirements
• Supports the development of presentations, scientific articles, and other materials for external engagement
• Coordinates the design of sampling protocols and sampling plans supporting PAT and analytics development
• Provides guidance to junior team members in all aspects of PA, as needed
• Other duties, as assigned

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Ability to adapt communication style to differing audiences and advise others on difficult matters
• Intermediate problem-solving and project management skills
• Proficient with Snowflake and Python
• Proficient with structured query language (SQL) writing skills
• Ability to perform advanced process analyses
• Ability to effectively present information to others
• Ability to provide feedback to others, including leaders
• Knowledge of regulatory requirements for data integrity and PAT
• Strong knowledge of process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)
• Proficient knowledge in SPC and multivariate data analysis

Basic Requirements

• Bachelor’s degree in Data Science, Biotechnology, Chemical Engineering with 5 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• Master’s degree with 3 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); or
• PhD with no prior experience
• Experience working in a GMP environment
• Experience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)
• Experience with machine learning techniques, data science techniques, and PAT

Preferred Requirements

• Experience with multivariate modeling and/or PAT application
• Prior biologics drug substance and manufacturing experience, including process development, validation, and transfer
• Experience leading new technology evaluations and/or method development
• Experience using Risk Management and RCA tools
• Experience working with a wide range of data analytics architectures (e.g., warehousing, distributed computing, visualization analytics)

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
Ability to discern audible cues. No X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No Yes
Ability to conduct work that includes moving objects up to X pounds. X No Yes If yes, 10 lbs. 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes

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 (FDBN_PNC@fujifilm.com).