Principal Process Engineer, Global Manufacturing Science and Technology, Cell Therapy Technical[...]

Socket.dev; Gaithersburg (MD); On-site; USD 122,312 - 183,469; Full time

Benefits offered by this job

Short-term incentive bonuses

Equity-based awards

Health, dental, and vision coverage

Job summary

AstraZeneca is seeking a Principal Process Engineer to oversee manufacturing processes in their cell therapy Global Manufacturing Science and Technology team. The successful candidate will manage technology transfer for clinical manufacturing, drive continuous process improvements, and ensure compliance with regulatory standards.

This role requires a strong educational background in Chemical or Biomedical Engineering and extensive experience in the cell therapy industry. The position offers competitive salary and benefits, including health coverage and retirement plans.

Qualifications

• Ph.D. with 4+ years; OR M.S. with 8+ years; OR B.S. with 10+ years of relevant experience.
• Hands-on expertise in cell therapy manufacturing processes and technologies.
• High standards of quality and accountability.

Responsibilities

• Lead technology transfer for clinical manufacturing and process monitoring.
• Manage post-approval process optimization and regulatory compliance.
• Collaborate with cross-functional teams for successful commercialization.

Skills

Technical oversight of manufacturing processes

Process validation

GMP manufacturing operations

Cross-functional collaboration

Education

B.S., M.S., or Ph.D. in Engineering or related discipline

Tools

Cell therapy manufacturing technologies

Job 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, including leading technology transfer for pivotal clinical manufacturing, process performance monitoring, defining process validation strategy, driving continuous process improvements, and authoring validation and regulatory deliverables to enable commercialization and lifecycle management across a global network of AstraZeneca’s manufacturing sites.

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, ensuring 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 control.
• Lifecycle Management – Provide technical oversight across the cell therapy manufacturing lifecycle from pivotal technology transfer, process validation, commercialization, and post‑approval; identify and implement process improvements that increase robustness, reduce cost of goods, improve plant throughput, and ensure supply continuity; manage post‑approval process optimization initiatives, comparability strategies, and regulatory risk mitigation; proactively identify and mitigate technical and operational risks and 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 – Work in close partnership with Late‑Stage Process Development (process definition, improvements, and characterization), Site MS&T (timely implementation of process changes), Quality (process compliance and product quality standards), CMC Regulatory (submission strategy and positioning), Supply Chain (long‑range planning and risk mitigation), and CMC Leadership (MSAT input for late‑stage development and commercial readiness).

Qualifications

• Education – B.S., 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 Expertise – Hands‑on expertise in cell therapy manufacturing processes and technologies; experience in viral vectors, vaccines, or biologics is desirable; extensive background in GMP manufacturing operations and technology transfer; process validation and CPV experience; authoring and defending CMC sections for major regulatory filings (INDa, BLA, MAA) and regulatory inspections.
• High standards of quality, accountability, and urgency with resilience to thrive in a fast‑paced cell & gene therapy field.

Salary & Benefits

Annual base pay ranges from $122,312.80 – $183,469.20. Positions offer eligibility for short‑term incentive bonuses, equity‑based awards for salaried roles, and commissions for sales roles. Benefits include qualified retirement programs, paid time off (vacation, holiday, and leaves), and health, dental, and vision coverage in accordance with the terms of the applicable plans.

Equal Employment Opportunity Statement

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.