LVV Downstream Process Scientist

AstraZeneca; Gaithersburg (MD); On-site; USD 110,000 - 170,000; Full time

Job summary

AstraZeneca in Gaithersburg, MD is seeking an experienced Scientist, Viral Vector Process Development (Downstream) to design, execute, and optimize scalable LVV purification processes for clinical and commercial scales.

You will lead hands-on experiments, contribute to DOE-driven process characterization, and support tech transfer to GMP sites and CDMOs while collaborating across Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external partners.

Qualifications

• Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology or related field with 0–2 years industry experience; or M.S. with 4–6 years.
• Hands-on downstream process development for LVV or viral vectors/biologics; familiarity with clinical/commercial scale and tech transfer.
• Proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding impurity profiles and control strategies.

Responsibilities

• Plan and perform scalable LVV downstream purification experiments focusing on yield, purity, potency, and consistency.
• Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation steps; define in-process controls.
• Design studies (DOE) to identify CPPs/CMAs, establish design space, and justify control strategies.
• Develop scale-down models; support scale-up to pilot/clinical/commercial equipment; assist tech transfer to GMP sites and CDMOs.
• Evaluate next-generation purification technologies to improve efficiency and product quality; contribute to continuous improvement.
• Draft high-quality protocols, reports, batch records, and CMC content for regulatory submissions; ensure cGMP and Quality systems alignment.
• Collaborate with upstream PD, Analytical Development, Manufacturing and Quality on parameter-attribute links.

Skills

Downstream PD

DOE & data analysis

QbD & risk assessment

Cross-functional collaboration

GMP compliance

Process characterization

Education

Ph.D. in Chemical Engineering

M.S. with 4–6 years experience

Tools

UF/DF/TFF

Chromatography

Filtration equipment

Tech transfer docs

Job description

AstraZeneca in Gaithersburg, MD is seeking an experienced Scientist, Viral Vector Process Development (Downstream) to design, execute, and optimize scalable LVV purification processes for clinical and commercial scales.

You will lead hands-on experiments, contribute to DOE-driven process characterization, and support tech transfer to GMP sites and CDMOs while collaborating across Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external partners.