Senior Process Engineer, Manufacturing Sciences & Technology, Cell Therapy
About The Position
AstraZeneca is seeking a Senior Process Engineer to join the site-based Manufacturing Sciences & Technology (MS&T) team at its Rockville, Maryland cell therapy manufacturing facility. The role supports robust, compliant, and cost-effective manufacturing of clinical and commercial cell therapy products through hands-on technical support, process and data analysis, investigations, continuous improvement, documentation, training, validation, and regulatory contributions. The work includes supporting technology transfers, clinical manufacturing, site readiness, process validation and PPQ, commercial manufacturing readiness, and product lifecycle management. The position reports to the Director, MS&T, Cell Therapy Development and Operations. The engineer serves as a primary interface among site Manufacturing, Quality, and Supply Chain, and global Process Development and CMC Regulatory functions. The position is on-site in Rockville, MD, requires approximately 15% domestic and international travel, and includes an on-call rotation during engineering, PPQ, and critical campaigns. Occasional off-shift support may be required.
Requirements
- PhD in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field, plus at least 1 year of industry experience; or an M.S. plus at least 5 years of hands-on industry experience; or a B.S. plus at least 8 years of hands-on industry experience.
- 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 in statistical analysis, including univariate and multivariate analysis and control charts.
- Accurate and thorough technical writing and clear, concise verbal communication.
- Strong data analysis and problem-solving skills.
- Excellent cross-functional communication and collaboration.
- Ability to translate complex data into clear decisions and regulatory-ready narratives.
- Ability to provide cross-functional leadership and communicate effectively under time-sensitive conditions.
- Ability to travel approximately 15% to other manufacturing facilities.
- Ability to participate in an on-call rotation during engineering, PPQ, and critical campaigns.
Nice To Haves
- Experience supporting late-stage clinical manufacturing of cell therapy products.
- Experience with process validation and commercial readiness of cell therapy products.
- Hands-on cell therapy unit-operation experience gained through process development and/or manufacturing.
- Expertise in technology transfer.
Responsibilities
- Provide day-to-day technical support for cell therapy manufacturing, including on-the-floor support for critical campaigns and occasional off-shift support.
- Represent Site MS&T at operational tier meetings and contribute to site activities.
- Maintain manufacturing data tracking systems and control charts; perform trend analyses, identify signals, and coordinate timely, documented signal-to-action.
- Review batch records, assess deviations, and trend data to monitor process performance and robustness.
- Lead or co-lead technical investigations of deviations and process excursions, perform root cause analysis, and develop and implement CAPAs.
- Identify, justify, and implement continuous improvements through cross-functional change controls, risk assessments, and comparability activities.
- Support qualification of critical raw materials, assess impacts of material changes, and contribute to second-source strategies.
- Partner with automation and digital manufacturing teams to implement electronic batch record improvements.
- Author and revise batch records, SOPs, technical documents, protocols, and summary reports while ensuring cGMP/ATMP compliance and data integrity.
- Deliver operator training on critical process steps and changes; contribute to lessons learned, playbooks, and cross-site best practices.
- Draft and review CMC Module 3 content and agency-question responses; support health authority and internal audits and inspections.
- Draft and review risk assessments and comparability study designs.
- Contribute to technology transfer packages, including process descriptions, URS inputs, bills of materials, and risk assessments; implement process changes; coordinate engineering runs and comparability or bridging studies; and author technical reports.
- Translate process characterization outputs from development into manufacturing controls and draft PPQ protocol and report sections.
- Provide technical support during scale-up, engineering runs, PPQ batches, and commercial manufacturing campaigns, including off-shift support when required.
- Serve as the primary interface between site Manufacturing, Quality, and Supply Chain and global Process Development and CMC Regulatory functions.
- Support cell therapy process lifecycle management, including continuous improvement initiatives and post-approval changes.
Benefits
- Eligibility for short-term incentive bonuses.
- Equity-based awards for salaried roles.
- Qualified retirement programs.
- Paid time off, including vacation, holidays, and leaves.
- Health coverage.
- Dental coverage.
- Vision coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
