Principal Process Engineer, Global Manufacturing Science and Technology, Ce at AstraZeneca

Gaithersburg, Maryland, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

220082.4

Posted On

05 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Cell Therapy Manufacturing, Technology Transfer, Process Validation, CMC Authoring, Continued Process Verification, GMP Manufacturing, Process Characterization, Regulatory Submissions, Lifecycle Management, Risk Mitigation, Change Control, Bioprocess Engineering

Industry

Pharmaceutical Manufacturing

Description

AstraZeneca is seeking an experienced principal process engineer for our cell therapy Global Manufacturing Science and Technology (MS&T) team. This position is responsible for the technical oversight of robust, compliant, and cost-effective end-to-end cell therapy manufacturing processes. Activities include leading technology transfer for pivotal clinical manufacturing, process performance monitoring, defining process validation strategy, driving implementation of continuous process improvements, and authoring validation and regulatory deliverables to enable commercialization and lifecycle management across a global network of AstraZeneca’s manufacturing sites. The position reports to the Associate Director, Global MS&T, is based in Gaithersburg, MD, and follows an onsite work model. The role requires up to 15% domestic and international travel. Responsibilities Development and Manufacturing Interface Represent Global MSAT in the technology transfer and process characterization teams to ensure successful commercialization of cell therapy products Represent Manufacturing Operations on product CMC teams, and ensure high-quality and timely program deliverables (clinical & commercial supply, site approvals) Develop PPQ readiness and PPQ execution technical framework for the site MSAT team and oversee execution at the manufacturing sites Develop proactive process analysis and Continued Process Verification (CPV) strategies across manufacturing sites to ensure continued process understanding and process control across all manufacturing sites Lifecycle Management Provide technical oversight across cell therapy manufacturing lifecycle — from pivotal manufacturing technology transfer, process validation, commercialization, and post-approval Identify and implement process improvements that increase process robustness, cost of goods, plant throughput, and supply continuity Manage post-approval process optimization initiatives, comparability strategies, ensuring scientific rigor and managing regulatory risks Proactively identify and mitigate technical and operational risks; drive lessons-learned cycles and standardization across sites and teams Regulatory & Quality Support Lead global Change Controls and ensure timely implementation and compliance Author CMC sections of regulatory submissions — Pivotal INDa, BLA, MAA, and supplements —with high efficiency and optimal content Partner with quality and regulatory to maintain full compliance with cGMP, ICH guidelines, and global regulatory expectations Develop and defend sound scientific justifications for the integrated control strategy and lifecycle changes Cross-Functional Partnerships You will work in close partnership with: Late-Stage Process Development — Ensure process definition, improvements, and process characterization reflect lifecycle strategy Site MS&T — partner to ensure timely implementation of process changes and improvements at the sites Quality — ensure process compliance and product quality standards CMC Regulatory — align on submission strategy and regulatory positioning Supply Chain — inform long-range supply planning and risk mitigation CMC Leadership — provide MSAT input for late-stage development and commercial readiness Qualifications Education B.S or M.S. or Ph.D. in Chemical/Biochemical/Biomedical Engineering, Bioengineering, Biochemistry, Biotechnology, Cell Biology, or a closely related discipline. Advanced degree preferred. Experience Ph.D. with 4+ years; OR M.S. with 8+ years, OR B.S. with 10+ years of relevant cell therapy/biologics/vaccines industry experience in technical development, MS&T, or CMO management areas. Technical and hands-on expertise in cell therapy manufacturing processes and technologies is highly desirable. Experience in viral vectors, vaccines, or biologics will be considered. Extensive background in GMP manufacturing operations and technology transfer. Experience in process validation and CPV. Experience in authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections. High standards of quality, accountability, and urgency — with the resilience to thrive in a fast-paced cell & gene therapy field. The annual base pay for this position ranges from $146,721.60 - $220,082.40. 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. Date Posted 04-Jul-2026 Closing Date 23-Jul-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. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

Provide technical oversight for end-to-end cell therapy manufacturing processes, including technology transfer and process validation. Lead the authoring of regulatory CMC deliverables and drive continuous process improvements across a global manufacturing network.