Process Analytics Scientist/Engineer 3

About This RoleThe 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.Company OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe 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 usWe 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.Job DescriptionWhat You'll DoCoordinates the execution of site readiness, technical transfer (TT), and ongoing manufacturing support activities by ensuring configuration and maintenance of compliant trending systemsPartners across functions to ensure alignment and delivers projects on time and in full completenessDevelops project plans that integrate with other scheduling functions within the organization and in alignment with program scopeEscalates risks and tracks milestone progress while ensuring cross functional communication to key stakeholdersBuilds and maintains routine statistical process control methods and multivariate models for process trending and monitoringPerforms ad hoc statistical analysis, as requiredCloses deviations and provides a thorough explanation of findings to internal and external teamsDocuments 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) perspectiveTrains 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 concernsSupports role in Good Manufacturing Practices (GMP) environmentLeads troubleshooting, process impact assessments, and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviationsGenerates and reviews master batch records (MBRs) and sample plans, as neededParticipates in site data stewardship and data activities to ensure data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholdersCoordinates 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 costCoordinates the curation of critical knowledge related to PA systems and multivariate modelingIdentifies, and supports the prioritization and planning of improvement opportunitiesContributes to the development of business cases and improvement plansWrites and reviews standard operating procedures (SOPs), work instructions, and white papers, and other relevant documentationBuilds awareness of industry trends and customer requirementsSupports the development of presentations, scientific articles, and other materials for external engagementCoordinates the design of sampling protocols and sampling plans supporting PAT and analytics developmentProvides guidance to junior team members in all aspects of PA, as neededOther duties, as assignedKnowledge and SkillsAbility to develop effective working relationships internally and externallyAbility to adapt communication style to differing audiences and advise others on difficult mattersIntermediate problem-solving and project management skillsProficient with Snowflake and PythonProficient with structured query language (SQL) writing skillsAbility to perform advanced process analysesAbility to effectively present information to othersAbility to provide feedback to others, including leadersKnowledge of regulatory requirements for data integrity and PATStrong knowledge of process historians and data management systems (e.g., OSI PI, Statistica, SIMCA)Proficient knowledge in SPC and multivariate data analysisBasic RequirementsBachelor's degree in Data Science, Biotechnology, Chemical Engineering with 5 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); orMaster's degree with 3 years of relevant experience (e.g., data engineering, manufacturing, bioprocess development, PAT); orPhD with no prior experienceExperience working in a GMP environmentExperience using Quality Systems (e.g., Deviation Management system, Change Control, CAPA, document management system)Experience with machine learning techniques, data science techniques, and PATPreferred RequirementsExperience with multivariate modeling and/or PAT applicationPrior biologics drug substance and manufacturing experience, including process development, validation, and transferExperience leading new technology evaluations and/or method developmentExperience using Risk Management and RCA toolsExperience working with a wide range of data analytics architectures (e.g., warehousing, distributed computing, visualization analytics)

Created: 2025-01-29