Senior Process Engineer, Viral Vector, Downstream

AstraZeneca is looking for a highly motivated and experiencedSenior Process Engineer Viral Vectorfordownstreamprocess development. The candidate will play a critical role in building and leading a high-performingteamthat accelerates AstraZenecas emerging Cell Therapy modalities portfolio. Youwill design execute andoptimizescalableLentiviral Vector (LVV)downstreampurificationprocesses with a primary focus onclinical and commercial scales. You 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 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 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: PhD in Biochemical/Chemical Engineering Biotechnology or related field with 25 years of relevant industry experience; or MS with 58 years; or BS with 810 years. Cell and gene therapy experience preferred.Titlewill becommensuratewith qualifications and experience.

• 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.

The annual base pay for this position ranges from $ 97372.00 - $146058.00. Base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program 401(k) plan; paid vacation and holidays; paid leaves; and health benefits including medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

At AstraZeneca we are at the forefront of innovation with constant new products and launches. Our dynamic environment encourages collaboration and problem-solving as we strive to deliver life-changing medicines. We embrace challenges in rapidly changing markets by continuously seeking better ways to deliver medicines to patients. Our team is diverse and connected globally working together to push the boundaries of supply chain excellence. With a focus on sustainability and a commitment to doing things the right way we offer opportunities for growth and development in a supportive environment.

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