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

AstraZeneca•Rockville, MD

5d•$103,286 - $154,930•Onsite

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 analysis, investigations, continuous improvement, and contributions to validation and regulatory activities. Work spans 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 role is on-site in Rockville and requires approximately 15% domestic and international travel, along with on-call and occasional off-shift support during engineering, PPQ, and critical manufacturing campaigns. The engineer provides day-to-day manufacturing support and collaborates across site Manufacturing, Quality, Supply Chain, Process Development, and CMC Regulatory. They support technology transfers and validation activities, help translate process development outputs into manufacturing controls, and contribute to lifecycle management and post-approval changes. The position requires hands-on cell therapy process experience, GMP knowledge, strong data analysis and technical writing skills, and the ability to communicate complex findings clearly. The annual base salary range is $103,286.40 to $154,929.60. The position may be eligible for short-term incentive bonuses and equity-based awards. Benefits include qualified retirement programs, paid time off (including vacation, holidays, and leaves), and health, dental, and vision coverage, subject to applicable plan terms.

Requirements

Bachelor of Science degree and at least 8 years of hands-on industry experience; or Master of Science degree and at least 4 years of hands-on industry experience; or Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field and at least 1 year of industry experience.
Strong technical and hands-on expertise in key cell therapy unit operations and common cell therapy processing equipment.
Demonstrated experience 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 skills and clear, concise verbal communication.
Strong data analysis and problem-solving skills.
Excellent cross-functional communication and collaboration skills.
Ability to translate complex data into clear decisions and regulatory-ready narratives.
Ability to demonstrate problem-solving, cross-functional leadership, and communication under time-sensitive conditions.
Ability to travel approximately 15% to other manufacturing facilities.
Availability for 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.
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 when required.
Represent Site MS&T at operational tier meetings and contribute to site activities.
Maintain manufacturing data tracking systems and control charts; analyze trends, identify signals, and coordinate timely action with clear documentation and cross-functional alignment.
Review batch records, assess deviations, and trend data to monitor process performance and manufacturing robustness.
Lead or co-lead technical investigations into deviations and process excursions, perform root cause analysis, and develop and implement data-supported CAPAs.
Identify, justify, and implement continuous improvements through cross-functional change controls, risk assessments, and comparability assessments.
Support qualification of critical raw materials, assess the impact 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 reports, protocols, and summary reports in alignment with cGMP/ATMP requirements and ALCOA+ data integrity principles.
Deliver operator training on critical process steps and changes, and contribute lessons learned, playbooks, and guidelines across sites.
Draft and review CMC Module 3 sections and responses to agency questions; 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 sections of PPQ protocols and reports.
Provide on-the-floor 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, site Quality, site Supply Chain, and global Process Development and CMC Regulatory functions.
Support cell therapy process lifecycle management, continuous improvement initiatives, and post-approval changes.