Principal Process Engineer, Manufacturing Sciences & Technology, Cell Therapy

About the Company

Responsibilities

• ● Manage, guide, and mentor MS&T engineer (s)
• ● Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing , including managing on-the-floor support for critical campaigns (including occasional off-shift support where required )
• ● Operations Support: Lead Site MS&T representation at operational tier meetings , pr oviding collaborative inputs that drive site activities
• ● Data trending and analysis : M aintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and cross-functional alignment.
• ● Process performance monitoring: Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes.
• ● Deviation/CAPA Support: Lead technical investigations for deviations and process excursions, perform root cause analysis, develop and implement CAPAs with appropriate data .
• ● Continuous improvements: Identify , justify, and implement continuous improvements by shepherding changes through cross functional change controls with appropriate risk assessments and comparability.
• ● Raw material s : Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and contribute to second-source strategies
• ● Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, manufacturing summary reports, ensure adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
• ● Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes ; Develop and drive lessons-learned, playbooks, and best practices across sites.
• ● Regulatory Contributions: Draft and review CMC sections (Module 3), response to agency question , support health authority and internal audits/inspections. Technology Transfer & Process Validation
• ● Draft and review r isk assessments and comparability stud y design
• ● Establish framework for New Product Introduction procedures and intake at the site
• ● Lead technology transfer activities (process descriptions, URS inputs, BOMs, risk assessments), implement process changes, coordinate execution of engineering runs and comparability/bridging studies, author technical reports
• ● Translate process characterization outputs from d evelopment into manufacturing controls, and draft sections of PPQ protocols/reports
• ● Provide and manage on the floor technical support during scale-out, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off - shift support when required ). Cross Functional Collaboration
• ● Serve as site MS&T lead at CMC and functional governance meetings
• ● Position serves as primary interface between site Manufacturing, site Quality, site Supply Chain, and global functions of Process Development and CMC regulatory
• ● Support lifecycle management for cell therapy processes , including continuous improvement initiatives and post-approval changes Required Qualifications Education