Senior LVV Upstream Process Engineer — Cell Therapy Scale-Up

AstraZeneca; Gaithersburg (MD); On-site; USD 112,000 - 168,000; Full time

Job summary

AstraZeneca is seeking a Senior Process Engineer to lead LVV upstream process development for viral vector manufacturing in Gaithersburg, MD. The role blends hands-on development with team leadership to accelerate cell therapy modalities, partnering across Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and CDMOs.

Responsibilities include designing and optimizing suspension LVV processes, executing scale‑up strategies, and driving tech transfer to internal GMP sites

Qualifications

• Ph.D. in chemical/biochemical engineering with 1+ year industry experience, or MS with 4+ years, or BS with 5+ years.
• Hands-on experience developing suspension LVV upstream processes for clinical and commercial scale.
• Experience with technology transfer and cGMP interfaces.
• Strong communication and teamwork skills; cross-functional collaboration.
• Experience with DOE and data analytics tools.

Responsibilities

• Plan and perform LVV upstream process development for suspension cell culture; target improvements in titer, quality, robustness, and cost.
• Execute unit operations across seed, production, and harvest; support scale‑up from bench to clinical scales; develop scale‑down models for characterization.
• Develop DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results.
• Contribute to design space, in‑process controls, and operating ranges; track KPIs and drive continuous improvement.
• Prepare tech transfer packages and support transfers to GMP sites and CDMOs; align with cGMP principles.

Skills

LVV Upstream Processes

Suspension cell culture

DOE / Data analysis

GMP readiness

Cross-functional collaboration

Education

Ph.D. in Chemical Engineering

Ph.D. in Biochemical Engineering

Ph.D. in Biotechnology

MS in Engineering

BS with 5+ years experience

Tools

Single-use rocking platform

Stirred-tank bioreactors

ELN/LIMS

Process automation/PAT

Job description

AstraZeneca is seeking a Senior Process Engineer to lead LVV upstream process development for viral vector manufacturing in Gaithersburg, MD. The role blends hands-on development with team leadership to accelerate cell therapy modalities, partnering across Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and CDMOs.

Responsibilities include designing and optimizing suspension LVV processes, executing scale‑up strategies, and driving tech transfer to internal GMP sites