Sr. Engineer 2, Process Analytics

Position Overview

The Senior Engineer or Scientist 2 of Process Analytics serves as the subject matter expert (SME) and provides technology transfer support, technical oversight, and strategic input across laboratory and manufacturing operations. This role leads junior team members through all aspects of process analytic (PA) activities and provides technical guidance and coaching.

Company Overview

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.

 

Job Description

What You’ll Do

• Provides oversight on all aspects of site readiness, technology transfer (TT) programs, and ongoing manufacturing activities related to process analytics (PA) deliverables
• Establishes and ensures timelines and plans align with relevant stakeholders and that deliverables are successfully completed on time
• Ensures team project plans are integrated 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
• Provides oversight on the execution and advancement of process trends and process verification plans
• Serves as the point of contact to customer and internal regulatory team for technical aspects of the process and program
• Facilitates delivery of documentation for internal and external use, such as comprehensive written manufacturing protocols and reports summarizing investigations, studies, and projects
• Serves as the subject matter expert (SME) while leading and conducting troubleshooting, process impact assessments, and executing root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Manages Chemistry, Manufacturing and Control (CMC) activities for development and manufacturing, including coordination and input to customer regulatory filings
• Identifies training needs and facilitates training for laboratory and manufacturing teamsOversees the development and roll-out of training content related to PA tools
• Supports role in Good Manufacturing Practices (GMP) environment
• Leads the technical team with investigating project challenges through risk assessment tools and techniques, as needed
• Closes deviations and provides a thorough explanation of findings to internal and external stakeholders
• Utilizes new knowledge to promptly drive data-based decisions
• Ensures master batch records (MBRs) and sample plans support PA requirements
• Negotiates with cross-functional stakeholders
• Oversees data stewardship and data governance activities, including alignment with global FDB network
• Ensures data and analyses are findable, accessible, interoperable, and reusable to internal and external stakeholders
• Leads best practices for TT and process performance qualification (PPQ) strategies globally, as required
• Oversees informatics and data systems improvement initiatives to improve scalability, manufacturability, reliability, yield and cost
• Serves as a key contributor to the PA strategic roadmap development and owns delivery of assigned items
• Communicates and aligns roadmap elements with internal and external stakeholders, as directed
• Oversees the evaluation of new analytical technologies (e.g., Process Analytical Technologies (PAT), Data Science tools) and the development of new