Scientist, Viral Vector Process Development (Downstream)

AstraZeneca is looking for a highly motivated and experiencedScientist Viral Vector Process Development (Downstream). The candidate will play a critical role in building a high-performingteamthat accelerates AstraZenecas emerging Cell Therapy modalities design execute andoptimizescalableLentiviral Vector LVV)downstreampurificationprocesses with a primary focus onclinical and commercial will contribute hands-on to experimental design process characterization and scale-up/tech transfer activities from research throughIND enabling partnering closely with Research Analytical Development CMC Regulatory Manufacturing Quality and external 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 andoptimizeclarification 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) toidentifyCPPs/CMAsestablishdesign 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 andassisttransfers 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: Practicalproficiencyin 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 withQbDprinciples 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;demonstratedproblem-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 processmonitoringand 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 ranges $92252 - $138378 USD Annual. Our positions offer eligibility for various incentivesan opportunity to receive short-term incentive bonuses equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs paid time off (i.e. vacation holiday and leaves) as well as health dental and vision coverage in accordance with the terms of the applicable plans.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.