Senior LVV Downstream Process Leader

AstraZeneca; Gaithersburg (MD); On-site; USD 142,000 - 214,000; Full time

Benefits offered by this job

401(k) plan

Health benefits

Job summary

AstraZeneca is seeking an Associate Principal Scientist to lead LVV downstream purification strategy from early development through clinical and commercial readiness. You will act as a technical authority and partner with Research, Upstream PD, Analytical Development, CMC, Manufacturing, QA, Regulatory, and external CDMOs.

You will oversee clarification, chromatography, UF/DF, and sterile filtration development; drive tech transfer to GMP sites; ensure cGMP compliance and data integrity; and

Qualifications

• MS with 10+ years of hands-on industry experience in downstream process development.
• PhD with 7+ years of hands-on industry experience in downstream process development.

Responsibilities

• Define end-to-end LVV downstream purification strategies for ex vivo and in vivo applications.
• Establish platform-aligned processes for IND-enabling, clinical, and commercial manufacturing.
• Lead matrixed project teams and coach scientists and engineers in downstream development.

Skills

LVV downstream

Cross-functional leadership

Tech leadership

Education

MS with 10+ years

PhD with 7+ years

Tools

Chromatography

UF/DF (TFF)

Sterile filtration

Job description

AstraZeneca is seeking an Associate Principal Scientist to lead LVV downstream purification strategy from early development through clinical and commercial readiness. You will act as a technical authority and partner with Research, Upstream PD, Analytical Development, CMC, Manufacturing, QA, Regulatory, and external CDMOs.

You will oversee clarification, chromatography, UF/DF, and sterile filtration development; drive tech transfer to GMP sites; ensure cGMP compliance and data integrity; and