Senior Process Engineer, Viral Vector, Upstream

AstraZeneca is looking for a highly motivated and experienced Senior Process Engineer for Viral Vector Upstream 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. You will design, execute, and optimize upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at 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 

• Upstream Process Development: Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, 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 use scale-down models for characterization and comparability. 

• Experimental Design & Data Analysis: Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fitforpurpose knowledge 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 with cGMP principles for late-stage readiness. 

• Cross-Functional Collaboration: Work closely with Analytical Development on assay readiness and inprocess testing; 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 time, rightfirsttime) and recommend improvements. 

Qualifications 

• Education: PhD in Chemical/Biomedical 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. Title will be commensurate with qualifications and experience. 

• Experience: Handson experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer. 

• Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, singleuse rocking-platform and stirred-tank bioreactors, and upstream–harvest interfaces; working knowledge of statistical DOE and data analytics tools. 

• GMP Readiness: Experience supporting cGMP interfaces (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 in crossfunctional, matrixed teams; demonstrated problemsolving and troubleshooting capability. 

• Tools & Automation: Experience with singleuse systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred. 

Preferred Qualifications 

• Demonstrated success scaling suspension LVV processes to 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. 

 

The annual base pay for this position ranges from $97,372.00 - $146,058.00. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In 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.

Join us in making a difference—apply today!

Compensation Pay Range:

97,372.00 - 146,058.00 USD Annual

The annual base pay (or hourly rate of compensation) for this position is outlined above. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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 salary (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.

Date Posted

09-Jan-2026

Closing Date

29-Jan-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In 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.