Senior LVV Downstream Process Scientist

AstraZeneca plc; Gaithersburg (MD); On-site; USD 142,000 - 213,000; Full time

Job summary

AstraZeneca plc in Gaithersburg, MD seeks an Associate Principal Scientist to lead LVV downstream process development, driving purification strategy from early development to clinical and commercial readiness.

The role requires leading cross-functional teams, advancing DOE/QbD initiatives, and ensuring cGMP compliance, with emphasis on scale-up and technology transfer to internal GMP sites and CDMOs.

Qualifications

• M.S. with 10+ years of hands-on industry experience in downstream process development.
• Ph.D. with 7+ years of hands-on industry experience in downstream process development.
• Extensive, hands-on LVV downstream process development or related viral vectors/biologics.
• Deep expertise in clarification, chromatography, UF/DF (TFF), and sterile filtration.
• Strong understanding of viral vector impurity profiles (HCP, host DNA) and mitigation.
• Experience supporting clinical and/or commercial scale processes including tech transfer.
• Knowledge of cGMP, Quality Systems, and FDA/EMA guidance for gene/cell therapies.
• Experience contributing to CMC sections of regulatory filings.
• Advanced statistics, DOE, and multivariate data interpretation.
• Strong application of QbD, risk management, and process justification.
• Excellent written and verbal communication; matrix leadership.

Responsibilities

• Define, develop, and execute LVV downstream purification strategies for IND-enabling to commercial manufacturing.
• Provide scientific leadership across clarification, chromatography, UF/DF, and sterile filtration.
• Lead cross-functional matrixed teams; align on strategy, timelines, and decisions.
• Coach scientists and engineers for downstream development activities.
• Design and qualify scale-down models; support scale-up to pilot and commercial equipment.
• Author and review technology transfer packages; enable successful CDMO transfer.
• Contribute to CMC strategies, control strategy, and in-process monitoring.
• Drive DOE, QbD, risk assessments, and root-cause investigations.
• Identify and evaluate new purification technologies and continuous improvement.
• Ensure compliance with cGMP, data integrity, and Quality Systems.

Skills

LVV downstream process development

Clarification

Chromatography

UF/DF (TFF)

Sterile filtration

DOE-based investigations

QbD principles

Risk assessments (FMEA)

Root cause investigations

Scientific leadership

Matrix leadership

Communication skills

Education

M.S. with 10+ years hands-on downstream experience

Ph.D. with 7+ years hands-on downstream experience

Job description

AstraZeneca plc in Gaithersburg, MD seeks an Associate Principal Scientist to lead LVV downstream process development, driving purification strategy from early development to clinical and commercial readiness.

The role requires leading cross-functional teams, advancing DOE/QbD initiatives, and ensuring cGMP compliance, with emphasis on scale-up and technology transfer to internal GMP sites and CDMOs.