Scientist, Viral Vector Process Development (Downstream)

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 is looking for a highly motivated and experienced Scientist, Viral Vector Process Development (Downstream). The candidate will play a critical role in building a high-performing team that accelerates AstraZeneca's emerging Cell Therapy modalities portfolio. You will design, execute, and optimize scalable Lentiviral Vector LVV) downstream purification processes with a primary focus on clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs. This position is based in Gaithersburg, MD.

Key Responsibilities

• Downstream Process Development : Plan and perform experiments to develop scalable, cost-effective LVV purification processes for ex vivo and in vivo applications, targeting yield, purity, potency, and consistency.
• Unit Operations Execution : Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation/fill-related steps; define phase-appropriate in-process controls and operating ranges.
• Process Characterization & Data Analysis : Design and analyze studies (including DOE) to identify CPPs/CMAs, establish design space, and justify control strategies; trend performance, conduct troubleshooting and root cause analysis, and recommend corrective actions.
• Scale-Up, Scale-Down & Tech Transfer Support : Develop representative scale-down models; support scale-up to pilot, clinical, and commercial-relevant equipment; prepare technical transfer documents and assist transfers to internal GMP sites and CDMOs.
• Novel Technologies & Continuous Improvement : Evaluate and implement next-generation purification technologies and consumables to improve efficiency, robustness, and product quality; contribute to continuous improvement initiatives.
• Documentation & Compliance : Author high-quality protocols, reports, batch records, and development summaries; support drafting of CMC content for regulatory submissions (e.g., IND) and align practices with cGMP and Quality systems expectations.
• Cross-Functional Collaboration : Partner with upstream PD and Analytical Development to link process parameters with product quality attributes (e.g., titer, infectivity/potency, residuals/impurities); collaborate with Manufacturing and Quality on operational feasibility and compliance.

Qualifications

• Education : Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 0-2 years of industry experience; OR M.S. with 4-6 years.
• Experience : Hands-on downstream process development for LVV (preferred) or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer.
• Technical Expertise : Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.
• Data & Risk Tools : Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification.
• GMP & Regulatory : Understanding of cGMP and Quality systems; familiarity with FDA/EMA guidance relevant to gene and cell therapy; experience contributing to CMC sections of regulatory filings is a plus.
• Communication & Collaboration : Strong written and verbal communication; ability to work effectively in cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting skills.

Preferred Qualifications

• Experience scaling LVV or other viral vector/biologic purification processes from preclinical to clinical/commercial-relevant equipment and consumables.
• Experience supporting tech transfer and implementation at internal sites and CDMOs.
• Exposure to PAT/digital tools for process monitoring and data integrity; experience with knowledge management systems.
• Demonstrated innovation in evaluating/implementing next-generation purification technologies.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca

Join a research-led organization where science and strategy meet to change clinical practice. You will work alongside experts who generate and communicate evidence that helps save lives, supported by a culture that values openness, shared learning, and the courage to try new ideas.

The annual base pay (or hourly rate of compensation) for this position ran