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AstraZeneca · 14 hours ago

Senior Process Engineer, Viral Vector, Downstream

Gaithersburg, MD

Full-time

Onsite

Mid, Senior Level

$97K/yr - $146K/yr

2+ years exp

AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer, Viral Vector, for downstream process development. The candidate will play a critical role in building and leading a high-performing team that accelerates AstraZeneca’s emerging Cell Therapy modalities portfolio.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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

Qualification

Downstream Process DevelopmentHands-on LVV DevelopmentTechnical Expertise in PurificationStatistical AnalysisDOEGMP & Regulatory KnowledgeCommunication SkillsCollaboration Skills

Required

PhD in Biochemical/Chemical Engineering, Biotechnology, or related field with 2–5 years of relevant industry experience; or MS with 5–8 years; or BS with 8–10 years

Hands-on downstream process development for LVV or other viral vectors/biologics; familiarity with clinical/commercial scale considerations and tech transfer

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

Working knowledge of statistical analysis and DOE; familiarity with QbD principles, risk assessments (e.g., FMEA), and process justification

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

Strong written and verbal communication; ability to work effectively in cross-functional, matrixed teams; demonstrated problem-solving and troubleshooting skills

Preferred

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

Benefits

Short-term incentive bonus opportunity

Eligibility to participate in our equity-based long-term incentive program

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (2)

2020 (11)