Senior Process Engineer, Manufacturing, Science, and Technology (MSAT) Cell Therapy

• Process Execution Support: Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns (including occasional off-shift support where required)
• Operations Support: Represent Site MS&T function at site operational tier meetings, providing collaborative inputs that drive site activities
• Data trending and analysis: Maintain manufacturing data tracking system and control charts, perform trend analyses, identify signals, and drive timely signal-to-action with clear documentation and multi-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 or co-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 multi-functional change controls with appropriate risk assessments and comparability.
• Raw materials: Support qualification of critical materials (e.g., cytokines, viral vector, single-use assemblies) and assess impact of raw material changes, and supply to second-source strategies
• Automation: Partner with automation/digital manufacturing teams to implement electronic batch record improvements
• Documentation & GMP Compliance: Author and revise batch records, SOPs, and technical reports; protocols, summary reports, ensure alignment to cGMP/ATMP requirements and data integrity principles (ALCOA+).
• Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; chip in to lessons-learned, playbooks, and guidelines across sites.
• Regulatory Contributions: Draft and review CMC sections (Module 3) response to agency question, support health authority and internal audits/inspections.

• Draft and review risk assessments and comparability study design
• Chip in to technology transfer packages (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 development into manufacturing controls, and draft sections of PPQ protocols/reports
• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required).

• 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

• Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment
• Demonstrated experience working in GMP environments, including batch record execution or review, deviations, and investigations.
• Proficiency with statistical analysis (including univariate, multi-variate analysis, control charts)
• Proven ability in accurate and thorough technical writing, paired with clear and concise verbal communication
• Strong data analysis, and problem‑solving skills.

• Excellent multi-functional communication and collaboration.
• Ability to translate complex data into clear decisions and regulatory-ready narratives.
• Excellent problem solving, multi-functional leadership, and communication under time-sensitive conditions.

• Experience with late‑stage clinical manufacturing support of cell therapy products
• Experience with process validation and commercial readiness of cell therapy products

• On-site in Rockville, MD
• Ability to travel ~15% to other manufacturing facilities
• On-call rotation during engineering/PPQ/critical campaigns

The annual base pay (or hourly rate of compensation) for this position ranges from $103,286.40 to $154,929.60. Our positions offer eligibility for various incentives - an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.