Key Responsibilities
Site manufacturing support
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 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 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 cross‑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 contribute 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 adherence to cGMP/ATMP requirements and data integrity principles (ALCOA+).
Training & Knowledge Transfer: Deliver operator training on critical process steps or process changes; contribute to 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 risk assessments and comparability study design
Contribute 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).
Cross‑Functional Collaboration
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
PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 5+ years of hands‑on industry experience, OR B.S. with 8+ years of hands‑on industry experience.
Technical Skills
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)
Demonstrated ability in accurate and thorough technical writing, paired with clear and concise verbal communication
Strong data analysis, and problem‑solving skills.
Soft skills
Excellent cross‑functional communication and collaboration.
Ability to translate complex data into clear decisions and regulatory-ready narratives.
Excellent problem solving, cross-functional leadership, and communication under time-sensitive conditions.
Preferred Qualifications
Experience with late‑stage clinical manufacturing support of cell therapy products
Experience with process validation and commercial readiness of cell therapy products
Work Environment
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 $94, 256.80 - $141, 385.20. 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.
Closing Date 26-Nov-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
