Senior Process Engineer, Viral Vector, Upstream
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Job Location:
Gaithersburg, MD - USA
Monthly Salary:
USD 97372 - 146058
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
AstraZeneca is looking for a highly motivated and experiencedSeniorProcess EngineerforViral VectorUpstreamProcess 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 andoptimizeupstream Lentiviral Vector (LVV) processes with a primary focus onsuspensionbioreactor platformsatclinical 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
Upstream Process Development: Plan and perform experiments to develop andoptimizeLVV upstream processes forsuspensioncell culture(transient orstableproducer cell systems) targeting improvements intiter quality robustness and cost.
Bioreactor Operations & Scale Translation: Execute unit operations across seed production and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and usescale-down modelsfor characterization and comparability.
Experimental Design & Data Analysis: Design DOE studiesidentifyCPPs/CMAs analyze data and propose control strategies; document results in protocols and reports; maintainfitforpurposeknowledge records.
Process Characterization & Control: Contribute to definition of design space in-process controls and operating ranges; trend process performance and drive troubleshooting root cause analysis and corrective actions.
Tech Transfer & GMP Interface: Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation withcGMPprinciples for late-stage readiness.
Cross-Functional Collaboration: Work closely with Analytical Development on assay readiness andinprocesstesting; partner with Manufacturing Supply and Quality to ensure operational feasibility and compliance.
Operational Excellence: Apply Lean practices and digital tools for scheduling data integrity and reproducibility; track KPIs (titer infectivity impurity profiles cycle timerightfirsttime) and recommend improvements.
Qualifications
Education: Ph.D. in Chemical Engineering Biochemical Engineering Biotechnology or related field with 1 years of industry experience; OR M.S. with 4 years; OR B.S. with 5 years of handson industry experience.
Experience: Handsonexperiencedevelopingsuspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations process characterization and technology transfer.
Technical Skills:Proficiencyin suspension cell culture transfection/infection strategies media/feed optimizationsingleuserocking-platform andstirred-tank bioreactors and upstreamharvest interfaces; working knowledge ofstatistical DOEand data analytics tools.
GMP Readiness: Experience supportingcGMPinterfaces (documentation change control sampling plans) and contributing to CMC sections or technical responses is a plus.
Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively incrossfunctional matrixed teams; demonstratedproblemsolvingand troubleshooting capability.
Tools & Automation: Experience withsingleusesystems process automation/PAT and digital lab systems (ELN/LIMS) preferred.
Preferred Qualifications
Demonstrated success scalingsuspension LVV processesto pilot/clinical scales and sustaining performance via monitoring and continuous improvement.
Experience linking upstream parameters to analytical outcomes (titer infectivity/potency residuals/impurities) to guide process decisions.
Contributions to regulatory filings (data tables process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.
Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.
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.
Join us in making a differenceapply today!
Date Posted
20-Jan-2026Closing Date
22-Jan-2026Our 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.
Required Experience:
Senior IC
Key Skills
- Distributed Control Systems
- Continuous Improvement
- Process Improvement
- Minitab
- Root cause Analysis
- Tooling
- Statistical Software
- Process Engineering
- cGMP
- Programmable Logic Controllers
- Public Speaking
- Manufacturing
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
